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FDA 510(k)

API UNISCEPT KB

K-Number: K850347 · 1985-03-26

ApplicantAnalytical Products, Inc.
Decision Date1985-03-26
Product CodeLTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API UNISCEPT KB is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K850347. The device is classified under product code LTW. 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 1985-03-26. The listed applicant is Analytical Products, Inc.. The 510(k) number is K850347.

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

API UNISCEPT KB received FDA 510(k) clearance on 1985-03-26, under 510(k) number K850347.

Who is the listed applicant for API UNISCEPT KB?

The FDA 510(k) record lists Analytical 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 LTW.

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Other records listing Analytical 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.

K924814API 20E/UNISCEPT 20EK923684API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MICK922926API UNISCEPT KB/TYPE 2 AND 3K901559MODIFICATION TO API UNISCEPT 20GPK901390DMAC INDOLE REAGENTK895796API UNISCEPT KB

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Related Devices (Code: LTW)

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.

K852613MIC-CONCEPT SYSTEMMicrotech Medical Systems, Inc.K853596PRECEPT CEFOPERAZONEAustin Biological LaboratoriesK853685PRECEPT TM CARBENICILLINAustin Biological LaboratoriesK853772PRECEPT METHICILLINAustin Biological LaboratoriesK853273PRECEPT CEFTRIAXONEAustin Biological LaboratoriesK853684PRECEPT KANAMYCINAustin Biological Laboratories

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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