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FDA 510(k)

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560

K-Number: K860773 · 1986-05-23

ApplicantClinical Sciences, Inc.
Decision Date1986-05-23
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K860773. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560?

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K860773.

When did TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 receive FDA 510(k) clearance?

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 received FDA 510(k) clearance on 1986-05-23, under 510(k) number K860773.

Who is the listed applicant for TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560?

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

What is the FDA product code for TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560?

The FDA product code for TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 is LGD.

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Other records listing Clinical Sciences, 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.

K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

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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