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FDA 510(k)

ENZYMATIC ALPHA-AMYLASE REAGENT KIT

K-Number: K850639 · 1985-03-05

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1985-03-05
Product CodeCIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC ALPHA-AMYLASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850639. 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 ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

ENZYMATIC ALPHA-AMYLASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K850639.

When did ENZYMATIC ALPHA-AMYLASE REAGENT KIT receive FDA 510(k) clearance?

ENZYMATIC ALPHA-AMYLASE REAGENT KIT received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850639.

Who is the listed applicant for ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATIC ALPHA-AMYLASE REAGENT KIT?

The FDA product code for ENZYMATIC ALPHA-AMYLASE REAGENT KIT is CIW.

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Other records listing Bio-Analytics Laboratories, Inc. 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK832771ERYTHROCYTE TEST

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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.K924339OLYMPUS AMYLASE REAGENTOlympus Corp.K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653Em Diagnostic Systems, 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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