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FDA 510(k)

OLYMPUS AMYLASE REAGENT

K-Number: K924339 · 1992-10-19

ApplicantOlympus Corp.
Decision Date1992-10-19
Product CodeCIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS AMYLASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1992-10-19 under 510(k) number K924339. The device is classified under product code CIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS AMYLASE REAGENT?

OLYMPUS AMYLASE REAGENT is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Olympus Corp.. The 510(k) number is K924339.

When did OLYMPUS AMYLASE REAGENT receive FDA 510(k) clearance?

OLYMPUS AMYLASE REAGENT received FDA 510(k) clearance on 1992-10-19, under 510(k) number K924339.

Who is the listed applicant for OLYMPUS AMYLASE REAGENT?

The FDA 510(k) record lists Olympus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS AMYLASE REAGENT?

The FDA product code for OLYMPUS AMYLASE REAGENT is CIW.

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Other records listing Olympus Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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Related Devices (Code: CIW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931559DMA AMYLASE PROCEDUREData Medical Associates, Inc.K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653Em Diagnostic Systems, Inc.K850639ENZYMATIC ALPHA-AMYLASE REAGENT KITBio-Analytics Laboratories, Inc.K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)Eastman Kodak CompanyK810584PHADEBAS ISOAMYLASE TESTPharmacia, Inc.K810669PANTRAK E.K.Calbiochem-Behring Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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