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FDA 510(k)

EL-B2GP1SCR

K-Number: K973882 · 1997-12-05

ApplicantTheratest Laboratories, Inc.
Decision Date1997-12-05
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EL-B2GP1SCR is the device name listed in this FDA 510(k) record. The listed applicant is Theratest Laboratories, Inc.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K973882. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EL-B2GP1SCR?

EL-B2GP1SCR is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K973882.

When did EL-B2GP1SCR receive FDA 510(k) clearance?

EL-B2GP1SCR received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973882.

Who is the listed applicant for EL-B2GP1SCR?

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

What is the FDA product code for EL-B2GP1SCR?

The FDA product code for EL-B2GP1SCR is MSV.

Other records listing Theratest Laboratories, 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.

K090753THERATEST EL-ANTI-CCP/2K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSK061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAK051066THERATEST EL-ANA PROFILES

View all 22 devices →

Related Devices (Code: MSV)

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.

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test 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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