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FDA 510(k)

IMMUSTRIP(TM) SM ELISA TEST SYSTEM

K-Number: K873741 · 1987-11-04

ApplicantImmunomedics, Inc.
Decision Date1987-11-04
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUSTRIP(TM) SM ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunomedics, Inc.. It received FDA 510(k) clearance on 1987-11-04 under 510(k) number K873741. 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 IMMUSTRIP(TM) SM ELISA TEST SYSTEM?

IMMUSTRIP(TM) SM ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1987-11-04. The listed applicant is Immunomedics, Inc.. The 510(k) number is K873741.

When did IMMUSTRIP(TM) SM ELISA TEST SYSTEM receive FDA 510(k) clearance?

IMMUSTRIP(TM) SM ELISA TEST SYSTEM received FDA 510(k) clearance on 1987-11-04, under 510(k) number K873741.

Who is the listed applicant for IMMUSTRIP(TM) SM ELISA TEST SYSTEM?

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

What is the FDA product code for IMMUSTRIP(TM) SM ELISA TEST SYSTEM?

The FDA product code for IMMUSTRIP(TM) SM ELISA TEST SYSTEM 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 Immunomedics, 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.

K972873IMMUSTRIP HAMA IGGK870903IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEMK861362IMMUNOMEDICS SERUM ELISA TEST SYSTEM

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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