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FDA 510(k)

MODELS IDA-2 PLUS AND IPT-1

K-Number: K961862 · 1997-02-26

ApplicantBio-Tek Instruments, Inc.
Decision Date1997-02-26
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODELS IDA-2 PLUS AND IPT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K961862. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MODELS IDA-2 PLUS AND IPT-1?

MODELS IDA-2 PLUS AND IPT-1 is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K961862.

When did MODELS IDA-2 PLUS AND IPT-1 receive FDA 510(k) clearance?

MODELS IDA-2 PLUS AND IPT-1 received FDA 510(k) clearance on 1997-02-26, under 510(k) number K961862.

Who is the listed applicant for MODELS IDA-2 PLUS AND IPT-1?

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

What is the FDA product code for MODELS IDA-2 PLUS AND IPT-1?

The FDA product code for MODELS IDA-2 PLUS AND IPT-1 is FRN.

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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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