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FDA 510(k)

WESBLOT RNP-SM TEST

K-Number: K881379 · 1988-05-16

ApplicantAmerican Bionetics, Inc.
Decision Date1988-05-16
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

WESBLOT RNP-SM TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Bionetics, Inc.. It received FDA 510(k) clearance on 1988-05-16 under 510(k) number K881379. 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 WESBLOT RNP-SM TEST?

WESBLOT RNP-SM TEST is a medical device that received FDA 510(k) clearance on 1988-05-16. The listed applicant is American Bionetics, Inc.. The 510(k) number is K881379.

When did WESBLOT RNP-SM TEST receive FDA 510(k) clearance?

WESBLOT RNP-SM TEST received FDA 510(k) clearance on 1988-05-16, under 510(k) number K881379.

Who is the listed applicant for WESBLOT RNP-SM TEST?

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

What is the FDA product code for WESBLOT RNP-SM TEST?

The FDA product code for WESBLOT RNP-SM TEST is LKP.

Related Clinical Trials

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.

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Other records listing American Bionetics, 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.

K884258VERSABLOTK874887WESBLOT PROCESSOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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