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FDA 510(k)

PLASMA POOLER HEAT SEALER

K-Number: K820301 · 1982-04-09

ApplicantNorth American Biologicals, Inc.
Decision Date1982-04-09
Product CodeKSD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLASMA POOLER HEAT SEALER is the device name listed in this FDA 510(k) record. The listed applicant is North American Biologicals, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820301. The device is classified under product code KSD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA POOLER HEAT SEALER?

PLASMA POOLER HEAT SEALER is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is North American Biologicals, Inc.. The 510(k) number is K820301.

When did PLASMA POOLER HEAT SEALER receive FDA 510(k) clearance?

PLASMA POOLER HEAT SEALER received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820301.

Who is the listed applicant for PLASMA POOLER HEAT SEALER?

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

What is the FDA product code for PLASMA POOLER HEAT SEALER?

The FDA product code for PLASMA POOLER HEAT SEALER is KSD.

Related Clinical Trials

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Other records listing North American Biologicals, 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.

K801219PLASMAPOOLERK801425RH CONTROLK781896BLOOD GROUP SUBSTANCE A,BK781895BLOOD GROUP SUBSTANCE BK781862BLOOD GROUP SUBSTANCE A

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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