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FDA 510(k)

COLORIMETRIC LDH REAGENT SET

K-Number: K820768 · 1982-04-14

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-04-14
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORIMETRIC LDH REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820768. The device is classified under product code CFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORIMETRIC LDH REAGENT SET?

COLORIMETRIC LDH REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K820768.

When did COLORIMETRIC LDH REAGENT SET receive FDA 510(k) clearance?

COLORIMETRIC LDH REAGENT SET received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820768.

Who is the listed applicant for COLORIMETRIC LDH REAGENT SET?

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

What is the FDA product code for COLORIMETRIC LDH REAGENT SET?

The FDA product code for COLORIMETRIC LDH REAGENT SET is CFH.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823211CK-UV REAGENTK823060HEMOGLOBIN REAGENTK822494OPTIMIZED UV-GPT REAGENT SETK822493OPTIMIZED UV-GOT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SET

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Related Devices (Code: CFH)

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.

K050790SPOTCHEM II LDH TESTArkray, Inc.K020484CARESIDE LDHCareside, Inc.K895138CLINISTAT LDH REAGENT TESTHeraeus Kulzer, Inc.K894578IQ LDHBd Becton Dickinson Vacutainer Systems PreanalyticK880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.K860349LACTATE DEHYDROGENASE (LDH) 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.

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