FDA 510(k)

TPP

K-Number: K962176 · 1996-10-18

Decision Date1996-10-18

Product CodeMIF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

TPP is the device name listed in this FDA 510(k) record. The listed applicant is Panbio, Inc.. It received FDA 510(k) clearance on 1996-10-18 under 510(k) number K962176. The device is classified under product code MIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TPP?

TPP is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Panbio, Inc.. The 510(k) number is K962176.

When did TPP receive FDA 510(k) clearance?

TPP received FDA 510(k) clearance on 1996-10-18, under 510(k) number K962176.

Who is the listed applicant for TPP?

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

What is the FDA product code for TPP?

The FDA product code for TPP is MIF.

Other records listing Panbio, 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.

K002024PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA K970189FIF TM K910636ABS CADKIT

Related Devices (Code: MIF)

K042687ENZYGNOST F+2 (MONOCLONAL) TEST KITDade Behring, Inc.K964934THROMBONOSTIKA F1.2Organon Teknika Corp.K922934ENZYGNOST F 1+2Behring Diagnostics, Inc.K920895DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISABaxter Diagnostics, Inc.K911434THROMBONOSTIKA F1.2Organon Teknika Corp.

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.