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FDA 510(k)

ULTRA ZYME PLUS GOT #64953, 65033 & 34

K-Number: K812592 · 1981-09-24

ApplicantHarleco
Decision Date1981-09-24
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA ZYME PLUS GOT #64953, 65033 & 34 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812592. 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 ULTRA ZYME PLUS GOT #64953, 65033 & 34?

ULTRA ZYME PLUS GOT #64953, 65033 & 34 is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Harleco. The 510(k) number is K812592.

When did ULTRA ZYME PLUS GOT #64953, 65033 & 34 receive FDA 510(k) clearance?

ULTRA ZYME PLUS GOT #64953, 65033 & 34 received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812592.

Who is the listed applicant for ULTRA ZYME PLUS GOT #64953, 65033 & 34?

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

What is the FDA product code for ULTRA ZYME PLUS GOT #64953, 65033 & 34?

The FDA product code for ULTRA ZYME PLUS GOT #64953, 65033 & 34 is CIT.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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