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FDA 510(k)

SINGLE VIAL LACTATE

K-Number: K780563 · 1978-04-18

ApplicantBoehringer Mannheim Corp.
Decision Date1978-04-18
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE VIAL LACTATE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-04-18 under 510(k) number K780563. 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 SINGLE VIAL LACTATE?

SINGLE VIAL LACTATE is a medical device that received FDA 510(k) clearance on 1978-04-18. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780563.

When did SINGLE VIAL LACTATE receive FDA 510(k) clearance?

SINGLE VIAL LACTATE received FDA 510(k) clearance on 1978-04-18, under 510(k) number K780563.

Who is the listed applicant for SINGLE VIAL LACTATE?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE VIAL LACTATE?

The FDA product code for SINGLE VIAL LACTATE is CFJ.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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