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FDA 510(k)

LACTATE DEHYDROGENASE (LDH) REAGENT SET

K-Number: K860349 · 1986-02-28

ApplicantSterling Diagnostics, Inc.
Decision Date1986-02-28
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE (LDH) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K860349. 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 LACTATE DEHYDROGENASE (LDH) REAGENT SET?

LACTATE DEHYDROGENASE (LDH) REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860349.

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

LACTATE DEHYDROGENASE (LDH) REAGENT SET received FDA 510(k) clearance on 1986-02-28, under 510(k) number K860349.

Who is the listed applicant for LACTATE DEHYDROGENASE (LDH) REAGENT SET?

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

What is the FDA product code for LACTATE DEHYDROGENASE (LDH) REAGENT SET?

The FDA product code for LACTATE DEHYDROGENASE (LDH) REAGENT SET is CFH.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) 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.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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