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FDA 510(k)

CLINISTAT LDH REAGENT TEST

K-Number: K895138 · 1989-10-19

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-10-19
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT LDH REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895138. 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 CLINISTAT LDH REAGENT TEST?

CLINISTAT LDH REAGENT TEST is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K895138.

When did CLINISTAT LDH REAGENT TEST receive FDA 510(k) clearance?

CLINISTAT LDH REAGENT TEST received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895138.

Who is the listed applicant for CLINISTAT LDH REAGENT TEST?

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

What is the FDA product code for CLINISTAT LDH REAGENT TEST?

The FDA product code for CLINISTAT LDH REAGENT TEST is CFH.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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.K894578IQ LDHBd Becton Dickinson Vacutainer Systems PreanalyticK880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.K860349LACTATE DEHYDROGENASE (LDH) REAGENT SETSterling Diagnostics, Inc.K852391EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDUREHelena Laboratories

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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