TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C— 510(k) K063766
Substantially EquivalentGood Biotech Corp.
FDA 510(k) clearance K063766 for TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C, Substantially Equivalent on 2007-04-23. Applicant: Good Biotech Corp.. Device class: 2.
Clearance details
- Applicant
- Good Biotech Corp.
- Product code
- Code DDG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5880
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung, TW
Recent devices under product code DDG
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- K050713 — DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
- K050576 — MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
- K022725 — CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
- K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
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