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FDA 510(k)

SERAQUEST ANTI-SM/RNP

K-Number: K980811 · 1998-05-12

ApplicantQuest Intl., Inc.
Decision Date1998-05-12
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERAQUEST ANTI-SM/RNP is the device name listed in this FDA 510(k) record. The listed applicant is Quest Intl., Inc.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K980811. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST ANTI-SM/RNP?

SERAQUEST ANTI-SM/RNP is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Quest Intl., Inc.. The 510(k) number is K980811.

When did SERAQUEST ANTI-SM/RNP receive FDA 510(k) clearance?

SERAQUEST ANTI-SM/RNP received FDA 510(k) clearance on 1998-05-12, under 510(k) number K980811.

Who is the listed applicant for SERAQUEST ANTI-SM/RNP?

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

What is the FDA product code for SERAQUEST ANTI-SM/RNP?

The FDA product code for SERAQUEST ANTI-SM/RNP is LKP.

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Other records listing Quest Intl., 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.

K091260SERAQUEST EBV EA-D IGG TESTK033915MODIFICATION TO SERAQUEST EB VCA IGGK033780MODIFICATION TO SERAQUEST VCA IGMK023593SERAQUEST ANTI-THYROID PEROXIDASE (TPO)K023592SERAQUEST ANTI-THYROGLOBULINK003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

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Related Devices (Code: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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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