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FDA 510(k)

RPR LIQUID CONTROLS

K-Number: K955143 · 1996-07-30

ApplicantRemel, L.P.
Decision Date1996-07-30
Product CodeGMP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPR LIQUID CONTROLS 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 1996-07-30 under 510(k) number K955143. The device is classified under product code GMP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPR LIQUID CONTROLS?

RPR LIQUID CONTROLS is a medical device that received FDA 510(k) clearance on 1996-07-30. The listed applicant is Remel, L.P.. The 510(k) number is K955143.

When did RPR LIQUID CONTROLS receive FDA 510(k) clearance?

RPR LIQUID CONTROLS received FDA 510(k) clearance on 1996-07-30, under 510(k) number K955143.

Who is the listed applicant for RPR LIQUID CONTROLS?

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 RPR LIQUID CONTROLS?

The FDA product code for RPR LIQUID CONTROLS is GMP.

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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 VANCOMYCINK964315REMEL STAPH LATEX KITK964421REMEL MEROPENEM 10UG SUSCEPTIBILITY DISKK96104610B ARGININE BROTHK955136RPR CARD TEST KITK961818GENTAMICIN DISK (120MCG)

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Related Devices (Code: GMP)

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.

K980638ADI SYPHILIS RPR LIQUID CONTROLSAmpcor Diagnostics, Inc.K961998QUALITROL SYPHSERO CONTROL SETConsolidated Technologies, Inc.K885298VISUWELL REAGIN TEST 960 TEST KITAllelix Diagnostics, Inc.K875180V-TREND RPRL CARD TESTTexas Immunology, Inc.K851504VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010Ncs Diagnostics, Inc.K843741RPR TEST REDITESTBiokit USA, 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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