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FDA 510(k)

MULTISTAT III X-HBDH TEST

K-Number: K771474 · 1977-09-13

ApplicantInstrumentation Laboratory CO
Decision Date1977-09-13
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTISTAT III X-HBDH TEST is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1977-09-13 under 510(k) number K771474. 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 MULTISTAT III X-HBDH TEST?

MULTISTAT III X-HBDH TEST is a medical device that received FDA 510(k) clearance on 1977-09-13. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K771474.

When did MULTISTAT III X-HBDH TEST receive FDA 510(k) clearance?

MULTISTAT III X-HBDH TEST received FDA 510(k) clearance on 1977-09-13, under 510(k) number K771474.

Who is the listed applicant for MULTISTAT III X-HBDH TEST?

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

What is the FDA product code for MULTISTAT III X-HBDH TEST?

The FDA product code for MULTISTAT III X-HBDH TEST is JMK.

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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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