FDA 510(k)

FIF TM

K-Number: K970189 · 1997-05-21

Decision Date1997-05-21

Product CodeKQJ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FIF TM is the device name listed in this FDA 510(k) record. The listed applicant is Panbio, Inc.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K970189. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIF TM?

FIF TM is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Panbio, Inc.. The 510(k) number is K970189.

When did FIF TM receive FDA 510(k) clearance?

FIF TM received FDA 510(k) clearance on 1997-05-21, under 510(k) number K970189.

Who is the listed applicant for FIF TM?

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 FIF TM?

The FDA product code for FIF TM is KQJ.

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 K962176TPP K910636ABS CADKIT

Related Devices (Code: KQJ)

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory CO K050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, Inc.K934326MULTIFIBREN UBehring Diagnostics, Inc.

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.