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FDA 510(k)

API UNISCEPT MIC/UNISCEPT MICRO-MIC

K-Number: K912964 · 1991-08-29

ApplicantAnalytab Products, Inc.
Decision Date1991-08-29
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API UNISCEPT MIC/UNISCEPT MICRO-MIC 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 1991-08-29 under 510(k) number K912964. 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 MIC/UNISCEPT MICRO-MIC?

API UNISCEPT MIC/UNISCEPT MICRO-MIC is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Analytab Products, Inc.. The 510(k) number is K912964.

When did API UNISCEPT MIC/UNISCEPT MICRO-MIC receive FDA 510(k) clearance?

API UNISCEPT MIC/UNISCEPT MICRO-MIC received FDA 510(k) clearance on 1991-08-29, under 510(k) number K912964.

Who is the listed applicant for API UNISCEPT MIC/UNISCEPT MICRO-MIC?

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 MIC/UNISCEPT MICRO-MIC?

The FDA product code for API UNISCEPT MIC/UNISCEPT MICRO-MIC is JWY.

Related Clinical Trials

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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.

K912965API UNISCEPT KBK861408MODIFIED UNISCEPT KB LABELING AMENDMENTK812877PENASEK812862API GERM TUBE

Related Devices (Code: JWY)

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.

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SAK260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher ScientificK250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher ScientificK252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

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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