FDA 510(k)

HEMATALL-C PLUS HEMATOLOGY CONTROLS

K-Number: K863224 · 1986-10-29

Decision Date1986-10-29

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEMATALL-C PLUS HEMATOLOGY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K863224. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATALL-C PLUS HEMATOLOGY CONTROLS?

HEMATALL-C PLUS HEMATOLOGY CONTROLS is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K863224.

When did HEMATALL-C PLUS HEMATOLOGY CONTROLS receive FDA 510(k) clearance?

HEMATALL-C PLUS HEMATOLOGY CONTROLS received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863224.

Who is the listed applicant for HEMATALL-C PLUS HEMATOLOGY CONTROLS?

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

What is the FDA product code for HEMATALL-C PLUS HEMATOLOGY CONTROLS?

The FDA product code for HEMATALL-C PLUS HEMATOLOGY CONTROLS is JPK.

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Other records listing Fisher Scientific Co., LLC as applicant

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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.