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FDA 510(k)

MODIFICATION MIC/API UNISCEPT(R)

K-Number: K884509 · 1988-11-22

ApplicantAnalytical Products, Inc.
Decision Date1988-11-22
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION MIC/API UNISCEPT(R) 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 1988-11-22 under 510(k) number K884509. 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 MODIFICATION MIC/API UNISCEPT(R)?

MODIFICATION MIC/API UNISCEPT(R) is a medical device that received FDA 510(k) clearance on 1988-11-22. The listed applicant is Analytical Products, Inc.. The 510(k) number is K884509.

When did MODIFICATION MIC/API UNISCEPT(R) receive FDA 510(k) clearance?

MODIFICATION MIC/API UNISCEPT(R) received FDA 510(k) clearance on 1988-11-22, under 510(k) number K884509.

Who is the listed applicant for MODIFICATION MIC/API UNISCEPT(R)?

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 MODIFICATION MIC/API UNISCEPT(R)?

The FDA product code for MODIFICATION MIC/API UNISCEPT(R) is JWY.

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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: JWY)

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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

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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