FDA 510(k) clearance · back to tracker

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

Cambridge Bioscience Corp. cleared K881894 on 1988-07-08, decision: substantially equivalent

K-number

K881894

Sponsor

Cambridge Bioscience Corp.

Device

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

Class

Class I

Decision

Substantially Equivalent

Decision date

1988-07-08

Product code

GOD

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3020

Official FDA record

Open K881894on accessdata.fda.gov →

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

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Raw record →

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

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Source

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