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FDA 510(k)

HBDH ENZYME KINETIC REAGENT SET

K-Number: K781720 · 1978-11-03

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

Device Summary

HBDH ENZYME KINETIC REAGENT SET 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 K781720. 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 HBDH ENZYME KINETIC REAGENT SET?

HBDH ENZYME KINETIC REAGENT SET 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 K781720.

When did HBDH ENZYME KINETIC REAGENT SET receive FDA 510(k) clearance?

HBDH ENZYME KINETIC REAGENT SET received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781720.

Who is the listed applicant for HBDH ENZYME KINETIC REAGENT SET?

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 HBDH ENZYME KINETIC REAGENT SET?

The FDA product code for HBDH ENZYME KINETIC REAGENT SET is JMK.

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Other records listing Medical Analysis Systems, 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.

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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.K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)Teco DiagnosticsK862319HBDH (OPTIMIZED) REAGENTSigma Chemical Co.K843774RAICHEM X-HBDH REAGENTReagents Applications, 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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