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FDA 510(k)

API UNISCEPT KB

K-Number: K912965 · 1991-09-06

ApplicantAnalytab Products, Inc.
Decision Date1991-09-06
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API UNISCEPT KB is the device name listed in this FDA 510(k) record. The listed applicant is Analytab Products, Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K912965. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the API UNISCEPT KB?

API UNISCEPT KB is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Analytab Products, Inc.. The 510(k) number is K912965.

When did API UNISCEPT KB receive FDA 510(k) clearance?

API UNISCEPT KB received FDA 510(k) clearance on 1991-09-06, under 510(k) number K912965.

Who is the listed applicant for API UNISCEPT KB?

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

What is the FDA product code for API UNISCEPT KB?

The FDA product code for API UNISCEPT KB is JWY.

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Other records listing Analytab Products, 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.

K912964API UNISCEPT MIC/UNISCEPT MICRO-MICK861408MODIFIED UNISCEPT KB LABELING AMENDMENTK812877PENASEK812862API GERM TUBE

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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.

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