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FDA 510(k)

REMEL STAPH LATEX KIT

K-Number: K964315 · 1997-02-07

ApplicantRemel, L.P.
Decision Date1997-02-07
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL STAPH LATEX KIT is the device name listed in this FDA 510(k) record. The listed applicant is Remel, L.P.. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K964315. 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 REMEL STAPH LATEX KIT?

REMEL STAPH LATEX KIT is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Remel, L.P.. The 510(k) number is K964315.

When did REMEL STAPH LATEX KIT receive FDA 510(k) clearance?

REMEL STAPH LATEX KIT received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964315.

Who is the listed applicant for REMEL STAPH LATEX KIT?

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

What is the FDA product code for REMEL STAPH LATEX KIT?

The FDA product code for REMEL STAPH LATEX KIT is JWX.

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Other records listing Remel, L.P. 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.

K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCINK964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKK96104610B ARGININE BROTHK955143RPR LIQUID CONTROLSK955136RPR CARD TEST KITK961819STREPTOMYCIN DISK (300MCG)

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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.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, Inc.K905617VISI-STAPHConnecticut Diagnostics, Ltd.

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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