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FDA 510(k)

AUTOPHOR 128

K-Number: K810047 · 1981-02-05

ApplicantGelman Sciences, Inc.
Decision Date1981-02-05
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOPHOR 128 is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K810047. The device is classified under product code JBD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPHOR 128?

AUTOPHOR 128 is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K810047.

When did AUTOPHOR 128 receive FDA 510(k) clearance?

AUTOPHOR 128 received FDA 510(k) clearance on 1981-02-05, under 510(k) number K810047.

Who is the listed applicant for AUTOPHOR 128?

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

What is the FDA product code for AUTOPHOR 128?

The FDA product code for AUTOPHOR 128 is JBD.

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Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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Related Devices (Code: JBD)

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.

K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K032862INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K992199ACID HEMOGLOBIN KITHelena LaboratoriesK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)MoraxK982426SPIFE ALKALINE HEMOGLOBINHelena LaboratoriesK931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories

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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