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FDA 510(k)

VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT

K-Number: K900688 · 1990-05-15

ApplicantClinical Sciences, Inc.
Decision Date1990-05-15
Product CodeLFY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT 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 1990-05-15 under 510(k) number K900688. The device is classified under product code LFY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT?

VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K900688.

When did VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT receive FDA 510(k) clearance?

VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT received FDA 510(k) clearance on 1990-05-15, under 510(k) number K900688.

Who is the listed applicant for VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT?

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 VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT?

The FDA product code for VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT is LFY.

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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.

K883870EPSTEIN-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. #5550K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

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Related Devices (Code: LFY)

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.

K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc.K070317ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEMZeus Scientific, Inc.K061820DIASORIN LIAISON VZV IGGDiaSorin, Inc.K051484ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.Zeus Scientific, Inc.K984181THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.K981867IS-VZU IGG TEST SYSTEMDiamedix Corp.

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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