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FDA 510(k)

ERYTHOCYTE CREATINE

K-Number: K852767 · 1986-11-13

ApplicantPanmed, Inc.
Decision Date1986-11-13
Product CodeJLA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ERYTHOCYTE CREATINE is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K852767. The device is classified under product code JLA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERYTHOCYTE CREATINE?

ERYTHOCYTE CREATINE is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Panmed, Inc.. The 510(k) number is K852767.

When did ERYTHOCYTE CREATINE receive FDA 510(k) clearance?

ERYTHOCYTE CREATINE received FDA 510(k) clearance on 1986-11-13, under 510(k) number K852767.

Who is the listed applicant for ERYTHOCYTE CREATINE?

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

What is the FDA product code for ERYTHOCYTE CREATINE?

The FDA product code for ERYTHOCYTE CREATINE is JLA.

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Other records listing Panmed, 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.

K820642SICKLE-CHECKK802161BIURET REAGENT & TOTAL PROTEIN BLANK SOLK802155REAGENTS SERUM SODIUM USING THE TECH.K802157BCG REAGENT SERUM ALBUMIN W/TECHNICONK802163CHLORIDE COLOR & CHLORIDE SAMPLE DILUENTK802159AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS

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Related Devices (Code: JLA)

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.

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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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