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FDA 510(k)

TINTELIZER(R) TPA

K-Number: K934314 · 1994-02-23

ApplicantBiopool AB
Decision Date1994-02-23
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TINTELIZER(R) TPA is the device name listed in this FDA 510(k) record. The listed applicant is Biopool AB. It received FDA 510(k) clearance on 1994-02-23 under 510(k) number K934314. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINTELIZER(R) TPA?

TINTELIZER(R) TPA is a medical device that received FDA 510(k) clearance on 1994-02-23. The listed applicant is Biopool AB. The 510(k) number is K934314.

When did TINTELIZER(R) TPA receive FDA 510(k) clearance?

TINTELIZER(R) TPA received FDA 510(k) clearance on 1994-02-23, under 510(k) number K934314.

Who is the listed applicant for TINTELIZER(R) TPA?

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

What is the FDA product code for TINTELIZER(R) TPA?

The FDA product code for TINTELIZER(R) TPA is GGP.

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Other records listing Biopool AB 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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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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