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FDA 510(k)

IMMUSTRIP HAMA IGG

K-Number: K972873 · 1998-03-17

ApplicantImmunomedics, Inc.
Decision Date1998-03-17
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUSTRIP HAMA IGG is the device name listed in this FDA 510(k) record. The listed applicant is Immunomedics, Inc.. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K972873. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUSTRIP HAMA IGG?

IMMUSTRIP HAMA IGG is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Immunomedics, Inc.. The 510(k) number is K972873.

When did IMMUSTRIP HAMA IGG receive FDA 510(k) clearance?

IMMUSTRIP HAMA IGG received FDA 510(k) clearance on 1998-03-17, under 510(k) number K972873.

Who is the listed applicant for IMMUSTRIP HAMA IGG?

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 HAMA IGG?

The FDA product code for IMMUSTRIP HAMA IGG is DAK.

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.

K873741IMMUSTRIP(TM) SM ELISA TEST SYSTEMK870903IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEMK861362IMMUNOMEDICS SERUM ELISA TEST SYSTEM

Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.K914388C1 RID KITThe Binding Site, Ltd.

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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