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FDA 510(k)

REAGENT SET, SGPT SERUM GLUTAMIC

K-Number: K781726 · 1978-11-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1978-11-03
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SET, SGPT SERUM GLUTAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781726. 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 REAGENT SET, SGPT SERUM GLUTAMIC?

REAGENT SET, SGPT SERUM GLUTAMIC is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781726.

When did REAGENT SET, SGPT SERUM GLUTAMIC receive FDA 510(k) clearance?

REAGENT SET, SGPT SERUM GLUTAMIC received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781726.

Who is the listed applicant for REAGENT SET, SGPT SERUM GLUTAMIC?

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

What is the FDA product code for REAGENT SET, SGPT SERUM GLUTAMIC?

The FDA product code for REAGENT SET, SGPT SERUM GLUTAMIC is CKA.

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Other records listing Medical Analysis Systems, Inc. as applicant

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K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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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