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FDA 510(k)

LDH REAGENT SET

K-Number: K812836 · 1981-10-09

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-10-09
Product CodeCFH
Advisory CommitteeCH
DecisionUnknown

Device Summary

LDH REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-10-09 under 510(k) number K812836. The device is classified under product code CFH. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LDH REAGENT SET?

LDH REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-10-09. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812836.

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

LDH REAGENT SET received FDA 510(k) clearance on 1981-10-09, under 510(k) number K812836.

Who is the listed applicant for LDH REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDH REAGENT SET?

The FDA product code for LDH REAGENT SET is CFH.

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Other records listing Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

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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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