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FDA 510(k)

ADI SYPHILIS RPR LIQUID CONTROLS

K-Number: K980638 · 1998-07-06

ApplicantAmpcor Diagnostics, Inc.
Decision Date1998-07-06
Product CodeGMP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADI SYPHILIS RPR LIQUID CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Ampcor Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-07-06 under 510(k) number K980638. 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 ADI SYPHILIS RPR LIQUID CONTROLS?

ADI SYPHILIS RPR LIQUID CONTROLS is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is Ampcor Diagnostics, Inc.. The 510(k) number is K980638.

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

ADI SYPHILIS RPR LIQUID CONTROLS received FDA 510(k) clearance on 1998-07-06, under 510(k) number K980638.

Who is the listed applicant for ADI SYPHILIS RPR LIQUID CONTROLS?

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

What is the FDA product code for ADI SYPHILIS RPR LIQUID CONTROLS?

The FDA product code for ADI SYPHILIS RPR LIQUID CONTROLS is GMP.

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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.

K961998QUALITROL SYPHSERO CONTROL SETConsolidated Technologies, Inc.K955143RPR LIQUID CONTROLSRemel, L.P.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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