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FDA 510(k)

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)

K-Number: K941427 · 1995-03-13

ApplicantTeco Diagnostics
Decision Date1995-03-13
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K941427. The device is classified under product code JMK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)?

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Teco Diagnostics. The 510(k) number is K941427.

When did SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) receive FDA 510(k) clearance?

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) received FDA 510(k) clearance on 1995-03-13, under 510(k) number K941427.

Who is the listed applicant for SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)?

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

What is the FDA product code for SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)?

The FDA product code for SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) is JMK.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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Related Devices (Code: JMK)

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.

K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610Polymer Technology Systems, Inc.K981865MTM BIOSCANNER K TEST STRIPSPolymer Technology Systems, Inc.K953452KETOREX C SANWAIhara Medics U.S., Inc.K862319HBDH (OPTIMIZED) REAGENTSigma Chemical Co.K843774RAICHEM X-HBDH REAGENTReagents Applications, Inc.K822739AHBDGilford Diagnostics

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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