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FDA 510(k)

SGPT REAGENT SET

K-Number: K821207 · 1982-07-14

ApplicantOmega Medical Electronics
Decision Date1982-07-14
Product CodeCKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGPT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821207. The device is classified under product code CKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SGPT REAGENT SET?

SGPT REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Omega Medical Electronics. The 510(k) number is K821207.

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

SGPT REAGENT SET received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821207.

Who is the listed applicant for SGPT REAGENT SET?

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

What is the FDA product code for SGPT REAGENT SET?

The FDA product code for SGPT REAGENT SET is CKD.

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Other records listing Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

View all 21 devices →

Related Devices (Code: CKD)

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.

K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772Cholestech Corp.K941192ORTHO ALT MICROWELL TEST SYSTEMOrtho Diagnostic Systems, Inc.K896237COBAS READY ALT REAGENTRoche Diagnostic Systems, Inc.K884784VIRGO(R) MICROWELL ALT ASSAYElectro-Nucleonics, Inc.K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.K864082REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp.

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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