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FDA 510(k)

LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.

K-Number: K860713 · 1986-04-24

ApplicantCatachem, Inc.
Decision Date1986-04-24
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K860713. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.?

LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Catachem, Inc.. The 510(k) number is K860713.

When did LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. receive FDA 510(k) clearance?

LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. received FDA 510(k) clearance on 1986-04-24, under 510(k) number K860713.

Who is the listed applicant for LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.?

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

What is the FDA product code for LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.?

The FDA product code for LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. is CFJ.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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Related Devices (Code: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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