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FDA 510(k)

DATA-ZYME LAT(GPT) PROCEDURE

K-Number: K801857 · 1980-09-16

ApplicantData Medical Associates, Inc.
Decision Date1980-09-16
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME LAT(GPT) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801857. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-ZYME LAT(GPT) PROCEDURE?

DATA-ZYME LAT(GPT) PROCEDURE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K801857.

When did DATA-ZYME LAT(GPT) PROCEDURE receive FDA 510(k) clearance?

DATA-ZYME LAT(GPT) PROCEDURE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801857.

Who is the listed applicant for DATA-ZYME LAT(GPT) PROCEDURE?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATA-ZYME LAT(GPT) PROCEDURE?

The FDA product code for DATA-ZYME LAT(GPT) PROCEDURE is CKA.

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Other records listing Data Medical Associates, Inc. as applicant

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K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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