FDA 510(k)

BECKMAN ICS NORMAL CONTROL SERA

K-Number: K812650 · 1981-10-19

Decision Date1981-10-19

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BECKMAN ICS NORMAL CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812650. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN ICS NORMAL CONTROL SERA?

BECKMAN ICS NORMAL CONTROL SERA is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K812650.

When did BECKMAN ICS NORMAL CONTROL SERA receive FDA 510(k) clearance?

BECKMAN ICS NORMAL CONTROL SERA received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812650.

Who is the listed applicant for BECKMAN ICS NORMAL CONTROL SERA?

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

What is the FDA product code for BECKMAN ICS NORMAL CONTROL SERA?

The FDA product code for BECKMAN ICS NORMAL CONTROL SERA is JJY.

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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.