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FDA 510(k)

COULTER ACCU-ZYME II GPT REAGENT

K-Number: K790522 · 1979-05-01

ApplicantCoulter Electronics, Inc.
Decision Date1979-05-01
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER ACCU-ZYME II GPT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790522. 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 COULTER ACCU-ZYME II GPT REAGENT?

COULTER ACCU-ZYME II GPT REAGENT is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K790522.

When did COULTER ACCU-ZYME II GPT REAGENT receive FDA 510(k) clearance?

COULTER ACCU-ZYME II GPT REAGENT received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790522.

Who is the listed applicant for COULTER ACCU-ZYME II GPT REAGENT?

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

What is the FDA product code for COULTER ACCU-ZYME II GPT REAGENT?

The FDA product code for COULTER ACCU-ZYME II GPT REAGENT is CKA.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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