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FDA 510(k)

SENSITITRE STABILITY PLATES

K-Number: K880641 · 1988-05-13

ApplicantSensititre , Ltd.
Decision Date1988-05-13
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE STABILITY PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Sensititre , Ltd.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K880641. 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 SENSITITRE STABILITY PLATES?

SENSITITRE STABILITY PLATES is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Sensititre , Ltd.. The 510(k) number is K880641.

When did SENSITITRE STABILITY PLATES receive FDA 510(k) clearance?

SENSITITRE STABILITY PLATES received FDA 510(k) clearance on 1988-05-13, under 510(k) number K880641.

Who is the listed applicant for SENSITITRE STABILITY PLATES?

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

What is the FDA product code for SENSITITRE STABILITY PLATES?

The FDA product code for SENSITITRE STABILITY PLATES is JWY.

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Other records listing Sensititre , Ltd. 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.

K960220SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESK911419SENSITITRE ARIS MODULE

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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