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FDA 510(k)

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI

K-Number: K810089 · 1981-01-26

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-01-26
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI 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 1981-01-26 under 510(k) number K810089. The device is classified under product code CGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI?

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K810089.

When did 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI receive FDA 510(k) clearance?

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810089.

Who is the listed applicant for 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI?

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 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI?

The FDA product code for 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI is CGE.

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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: CGE)

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.

K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.Alpkem Corp.K855185GLUCOSE REAGENT SETTechnostics Intl.K850930GLUCOSEDilab, Inc.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing 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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