Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HYDROXYBUTYRATE DEHYDROGENASE REAGENT

K-Number: K834084 · 1984-02-04

ApplicantSterling Biochemical, Inc.
Decision Date1984-02-04
Product CodeJKF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDROXYBUTYRATE DEHYDROGENASE REAGENT 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 1984-02-04 under 510(k) number K834084. The device is classified under product code JKF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROXYBUTYRATE DEHYDROGENASE REAGENT?

HYDROXYBUTYRATE DEHYDROGENASE REAGENT is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K834084.

When did HYDROXYBUTYRATE DEHYDROGENASE REAGENT receive FDA 510(k) clearance?

HYDROXYBUTYRATE DEHYDROGENASE REAGENT received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834084.

Who is the listed applicant for HYDROXYBUTYRATE DEHYDROGENASE REAGENT?

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 HYDROXYBUTYRATE DEHYDROGENASE REAGENT?

The FDA product code for HYDROXYBUTYRATE DEHYDROGENASE REAGENT is JKF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SETK834045URIC ACID REAGENT SET

View all 15 devices →

Related Devices (Code: JKF)

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.

K861855HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SETSterling Diagnostics, 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.

↑