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FDA 510(k)

GLYCOHEMOGLOBIN

K-Number: K810958 · 1981-09-16

ApplicantMacomb Chemical Co.
Decision Date1981-09-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOHEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K810958. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOHEMOGLOBIN?

GLYCOHEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Macomb Chemical Co.. The 510(k) number is K810958.

When did GLYCOHEMOGLOBIN receive FDA 510(k) clearance?

GLYCOHEMOGLOBIN received FDA 510(k) clearance on 1981-09-16, under 510(k) number K810958.

Who is the listed applicant for GLYCOHEMOGLOBIN?

The FDA 510(k) record lists Macomb Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCOHEMOGLOBIN?

The FDA product code for GLYCOHEMOGLOBIN is LCP.

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Other records listing Macomb Chemical Co. 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEOK792533CREATINE PHOSPHOKINASE (CPK) REAGENT SET

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Related Devices (Code: LCP)

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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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