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FDA 510(k)

RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600

K-Number: K891990 · 1989-06-15

ApplicantClinical Sciences, Inc.
Decision Date1989-06-15
Product CodeLJB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 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 1989-06-15 under 510(k) number K891990. The device is classified under product code LJB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600?

RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K891990.

When did RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 receive FDA 510(k) clearance?

RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 received FDA 510(k) clearance on 1989-06-15, under 510(k) number K891990.

Who is the listed applicant for RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600?

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 RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600?

The FDA product code for RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 is LJB.

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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 #5590K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

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Related Devices (Code: LJB)

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.

K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.K922335BARTELS RUBEOLA IGM EIABaxter Diagnostics, Inc.K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.K904083RUBEOLA IGM ELISA TESTGull Laboratories, 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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