FDA 510(k)

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS

K-Number: K883394 · 1988-09-07

Decision Date1988-09-07

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K883394. 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 GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS?

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K883394.

When did GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS receive FDA 510(k) clearance?

GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS received FDA 510(k) clearance on 1988-09-07, under 510(k) number K883394.

Who is the listed applicant for GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS?

The FDA product code for GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS is JWY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Healthcare Corp as applicant

K190910PrisMax System Version 2 K163530PrisMax Control Unit K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO K123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

View all 504 devices →

Related Devices (Code: JWY)

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA K260696MTS 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 Scientific K250575The 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 Scientific K252014The 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.