FDA 510(k)

HEMO-SOL

K-Number: K874461 · 1987-12-04

Decision Date1987-12-04

Product CodeKEM

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

HEMO-SOL is the device name listed in this FDA 510(k) record. The listed applicant is Chem Pharm, Inc.. It received FDA 510(k) clearance on 1987-12-04 under 510(k) number K874461. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-SOL?

HEMO-SOL is a medical device that received FDA 510(k) clearance on 1987-12-04. The listed applicant is Chem Pharm, Inc.. The 510(k) number is K874461.

When did HEMO-SOL receive FDA 510(k) clearance?

HEMO-SOL received FDA 510(k) clearance on 1987-12-04, under 510(k) number K874461.

Who is the listed applicant for HEMO-SOL?

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

What is the FDA product code for HEMO-SOL?

The FDA product code for HEMO-SOL is KEM.

Related Devices (Code: KEM)

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.

K881282XYLENEAnatech, Ltd.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena Laboratories K855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K853694XYLENE SUBSTITUTELerner Laboratories, Inc.K842861PRO-PAR CLEARANTAnatech, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.