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FDA 510(k)

MODIFIED HAM'S F-10 W/ALBUMIN

K-Number: K894432 · 1989-09-22

ApplicantIrvine Scientific
Decision Date1989-09-22
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFIED HAM'S F-10 W/ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific. It received FDA 510(k) clearance on 1989-09-22 under 510(k) number K894432. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED HAM'S F-10 W/ALBUMIN?

MODIFIED HAM'S F-10 W/ALBUMIN is a medical device that received FDA 510(k) clearance on 1989-09-22. The listed applicant is Irvine Scientific. The 510(k) number is K894432.

When did MODIFIED HAM'S F-10 W/ALBUMIN receive FDA 510(k) clearance?

MODIFIED HAM'S F-10 W/ALBUMIN received FDA 510(k) clearance on 1989-09-22, under 510(k) number K894432.

Who is the listed applicant for MODIFIED HAM'S F-10 W/ALBUMIN?

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

What is the FDA product code for MODIFIED HAM'S F-10 W/ALBUMIN?

The FDA product code for MODIFIED HAM'S F-10 W/ALBUMIN is HDR.

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Other records listing Irvine Scientific 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.

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Related Devices (Code: HDR)

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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