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FDA 510(k)

LDH-INT TEST

K-Number: K771343 · 1977-08-10

ApplicantHycel, Inc.
Decision Date1977-08-10
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LDH-INT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-08-10 under 510(k) number K771343. 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 LDH-INT TEST?

LDH-INT TEST is a medical device that received FDA 510(k) clearance on 1977-08-10. The listed applicant is Hycel, Inc.. The 510(k) number is K771343.

When did LDH-INT TEST receive FDA 510(k) clearance?

LDH-INT TEST received FDA 510(k) clearance on 1977-08-10, under 510(k) number K771343.

Who is the listed applicant for LDH-INT TEST?

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

What is the FDA product code for LDH-INT TEST?

The FDA product code for LDH-INT TEST is CFH.

Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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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