FDA 510(k) clearance · back to tracker

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS

Bioscan Instruments, Inc. cleared K875248 on 1988-02-24, decision: substantially equivalent

K-number

K875248

Sponsor

Bioscan Instruments, Inc.

Device

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS

Class

Class I

Decision

Substantially Equivalent

Decision date

1988-02-24

Product code

JMT

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1510

Official FDA record

Open K875248on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K875248 into Compass and start a substantial-equivalence draft.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.