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FDA 510(k)

LIPASE REAGENT SET

K-Number: K831874 · 1983-08-12

ApplicantSterling Biochemical, Inc.
Decision Date1983-08-12
Product CodeJGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Biochemical, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831874. The device is classified under product code JGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE REAGENT SET?

LIPASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K831874.

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

LIPASE REAGENT SET received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831874.

Who is the listed applicant for LIPASE REAGENT SET?

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

What is the FDA product code for LIPASE REAGENT SET?

The FDA product code for LIPASE REAGENT SET is JGX.

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Other records listing Sterling Biochemical, Inc. 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.

K844998GLUCOSE(HEXOKINASE) REAGENT SETK844251ALT/GPT REAGENT SETK843332ALKALINE PHOSPHATASE REAGENT SETK842521AST/GOT REAGENT SET UV RATEK840064UREA NITROGEN REAGENT SETK834084HYDROXYBUTYRATE DEHYDROGENASE REAGENT

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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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