FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
K Number: K050713
·
Decision Jun 6, 2005
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
8
Review Days
80
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Basic Information
- Device Name
- DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
- K Number
- K050713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Good Biotech Corp.
- Date Received
- March 18, 2005
- Decision Date
- June 6, 2005
- Product Code
- DCN
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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Other Clearances by Good Biotech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C | Apr 23, 2007 | Substantially Equivalent |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Feb 23, 2006 | Substantially Equivalent |
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | Apr 21, 2005 | Substantially Equivalent |
| K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 | Sep 23, 2002 | Substantially Equivalent |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET | Jul 29, 2002 | Substantially Equivalent |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | Jul 11, 2002 | Substantially Equivalent |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | Jun 13, 2002 | Substantially Equivalent |