CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510— 510(k) K021882
Substantially EquivalentGood Biotech Corp.
FDA 510(k) clearance K021882 for CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510, Substantially Equivalent on 2002-07-11. Applicant: Good Biotech Corp.. Device class: 2.
Clearance details
- Applicant
- Good Biotech Corp.
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, CN
Recent devices under product code DCN
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- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.