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FDA 510(k)

CHEM-STRATE AMYLASE

K-Number: K792479 · 1979-12-27

ApplicantGeneral Diagnostics
Decision Date1979-12-27
Product CodeCIJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-STRATE AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1979-12-27 under 510(k) number K792479. The device is classified under product code CIJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM-STRATE AMYLASE?

CHEM-STRATE AMYLASE is a medical device that received FDA 510(k) clearance on 1979-12-27. The listed applicant is General Diagnostics. The 510(k) number is K792479.

When did CHEM-STRATE AMYLASE receive FDA 510(k) clearance?

CHEM-STRATE AMYLASE received FDA 510(k) clearance on 1979-12-27, under 510(k) number K792479.

Who is the listed applicant for CHEM-STRATE AMYLASE?

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

What is the FDA product code for CHEM-STRATE AMYLASE?

The FDA product code for CHEM-STRATE AMYLASE is CIJ.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: CIJ)

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.

K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.K980013AMYLASEAc Biochemicals, Inc.K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,

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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