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FDA 510(k)

RAICHEM X-HBDH REAGENT

K-Number: K843774 · 1984-10-31

ApplicantReagents Applications, Inc.
Decision Date1984-10-31
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM X-HBDH REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K843774. 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 RAICHEM X-HBDH REAGENT?

RAICHEM X-HBDH REAGENT is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K843774.

When did RAICHEM X-HBDH REAGENT receive FDA 510(k) clearance?

RAICHEM X-HBDH REAGENT received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843774.

Who is the listed applicant for RAICHEM X-HBDH REAGENT?

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

What is the FDA product code for RAICHEM X-HBDH REAGENT?

The FDA product code for RAICHEM X-HBDH REAGENT 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.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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