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FDA 510(k)

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013

K-Number: K022725 · 2002-09-23

ApplicantGood Biotech Corp.
Decision Date2002-09-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 is the device name listed in this FDA 510(k) record. The listed applicant is Good Biotech Corp.. It received FDA 510(k) clearance on 2002-09-23 under 510(k) number K022725. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013?

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 is a medical device that received FDA 510(k) clearance on 2002-09-23. The listed applicant is Good Biotech Corp.. The 510(k) number is K022725.

When did CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 receive FDA 510(k) clearance?

CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 received FDA 510(k) clearance on 2002-09-23, under 510(k) number K022725.

Who is the listed applicant for CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013?

The FDA 510(k) record lists Good Biotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013?

The FDA product code for CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 is JJX.

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Other records listing Good Biotech Corp. 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.

K063766TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,CK052617FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,K050713DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-HK021757CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SETK021882CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

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Related Devices (Code: JJX)

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K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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