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FDA 510(k)

IDA-4 AND IPT-MC

K-Number: K973609 · 1997-12-18

ApplicantBio-Tek Instruments, Inc.
Decision Date1997-12-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

IDA-4 AND IPT-MC 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 1997-12-18 under 510(k) number K973609. 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 IDA-4 AND IPT-MC?

IDA-4 AND IPT-MC is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K973609.

When did IDA-4 AND IPT-MC receive FDA 510(k) clearance?

IDA-4 AND IPT-MC received FDA 510(k) clearance on 1997-12-18, under 510(k) number K973609.

Who is the listed applicant for IDA-4 AND IPT-MC?

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 IDA-4 AND IPT-MC?

The FDA product code for IDA-4 AND IPT-MC is FRN.

Other records listing Bio-Tek Instruments, 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.

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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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