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FDA 510(k)

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208

K-Number: K984479 · 1998-12-22

ApplicantBio-Rad
Decision Date1998-12-22
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K984479. 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 LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208?

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Bio-Rad. The 510(k) number is K984479.

When did LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 receive FDA 510(k) clearance?

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 received FDA 510(k) clearance on 1998-12-22, under 510(k) number K984479.

Who is the listed applicant for LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208?

The FDA product code for LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 is LKP.

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Other records listing Bio-Rad as applicant

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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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