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FDA 510(k)

ULTRAZYME PLUS GOT, #64953,65033&65034

K-Number: K821467 · 1982-06-01

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-01
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS GOT, #64953,65033&65034 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K821467. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS GOT, #64953,65033&65034?

ULTRAZYME PLUS GOT, #64953,65033&65034 is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821467.

When did ULTRAZYME PLUS GOT, #64953,65033&65034 receive FDA 510(k) clearance?

ULTRAZYME PLUS GOT, #64953,65033&65034 received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821467.

Who is the listed applicant for ULTRAZYME PLUS GOT, #64953,65033&65034?

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

What is the FDA product code for ULTRAZYME PLUS GOT, #64953,65033&65034?

The FDA product code for ULTRAZYME PLUS GOT, #64953,65033&65034 is CIT.

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Other records listing Emd Chemicals, Inc. as applicant

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K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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