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FDA 510(k)

SGPT/ALT REAGENT SYSTEM

K-Number: K780791 · 1978-06-13

ApplicantAmerican Monitor Corp.
Decision Date1978-06-13
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGPT/ALT REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780791. 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 SGPT/ALT REAGENT SYSTEM?

SGPT/ALT REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is American Monitor Corp.. The 510(k) number is K780791.

When did SGPT/ALT REAGENT SYSTEM receive FDA 510(k) clearance?

SGPT/ALT REAGENT SYSTEM received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780791.

Who is the listed applicant for SGPT/ALT REAGENT SYSTEM?

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

What is the FDA product code for SGPT/ALT REAGENT SYSTEM?

The FDA product code for SGPT/ALT REAGENT SYSTEM is CKA.

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Other records listing American Monitor Corp. 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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