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FDA 510(k)

RAPI - STAPH

K-Number: K852997 · 1985-08-19

ApplicantAdvanced Medical Technology, Inc.
Decision Date1985-08-19
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPI - STAPH is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Technology, Inc.. It received FDA 510(k) clearance on 1985-08-19 under 510(k) number K852997. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPI - STAPH?

RAPI - STAPH is a medical device that received FDA 510(k) clearance on 1985-08-19. The listed applicant is Advanced Medical Technology, Inc.. The 510(k) number is K852997.

When did RAPI - STAPH receive FDA 510(k) clearance?

RAPI - STAPH received FDA 510(k) clearance on 1985-08-19, under 510(k) number K852997.

Who is the listed applicant for RAPI - STAPH?

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

What is the FDA product code for RAPI - STAPH?

The FDA product code for RAPI - STAPH is JWX.

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.

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Other records listing Advanced Medical Technology, 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.

K083626DISTRACTABLE WAVE CAGEK874571PATIENTWATCH (TM)K862777MODEL A-8000 ULTRASONIC HANDPIECE CORDK854225ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYSK853187ACRIDINE ORANGE FLUORESCENT STAINK853081AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET

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Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, Inc.

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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