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FDA 510(k)

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

K-Number: K050576 · 2005-04-21

ApplicantGood Biotech Corp.
Decision Date2005-04-21
Product CodeDDZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H 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 2005-04-21 under 510(k) number K050576. The device is classified under product code DDZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H?

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Good Biotech Corp.. The 510(k) number is K050576.

When did MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H receive FDA 510(k) clearance?

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050576.

Who is the listed applicant for MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H?

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 MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H?

The FDA product code for MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H is DDZ.

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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: 4511K022725CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013K021757CRPEX-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: DDZ)

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.

K023860MICROALBUMIN REAGENT SET AND CALIBRATORSPointe Scientific, Inc.,K002674RANDOX MICROALBUMINRandox Laboratories, Ltd.K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-Dako 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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