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FDA 510(k)

MIC - CONCEPT(TM) RX-2

K-Number: K863847 · 1986-12-18

ApplicantMicrotech Medical Systems, Inc.
Decision Date1986-12-18
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MIC - CONCEPT(TM) RX-2 is the device name listed in this FDA 510(k) record. The listed applicant is Microtech Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-12-18 under 510(k) number K863847. 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 MIC - CONCEPT(TM) RX-2?

MIC - CONCEPT(TM) RX-2 is a medical device that received FDA 510(k) clearance on 1986-12-18. The listed applicant is Microtech Medical Systems, Inc.. The 510(k) number is K863847.

When did MIC - CONCEPT(TM) RX-2 receive FDA 510(k) clearance?

MIC - CONCEPT(TM) RX-2 received FDA 510(k) clearance on 1986-12-18, under 510(k) number K863847.

Who is the listed applicant for MIC - CONCEPT(TM) RX-2?

The FDA 510(k) record lists Microtech Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIC - CONCEPT(TM) RX-2?

The FDA product code for MIC - CONCEPT(TM) RX-2 is JWY.

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Other records listing Microtech Medical Systems, 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.

K935485FAS FASTIDIOUS MIC PANELK901598FASTIDIOUS MIC PANELK896332SUPPLEMENT TO ANAEROBIC MIC PANELK884831ANAEROBIC MIC PANELK861774QUADRA-TITER (TM) I.D. (MODIFICATION)K860208QUADRA-TITER I.D.

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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

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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