ALDOCTK-125
FDA 510(k) clearance K800775 · decided 1980-04-21
Clearance details
- K-number
- K800775
- Device name
- ALDOCTK-125
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-07
- Decision date
- 1980-04-21
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CJM
- Device class
- 2
- Regulation number
- 862.1045
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S003) | Sorin Biomedica, Fiat, USA, Inc. | 1987-02-17 |
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S002) | Sorin Biomedica, Fiat, USA, Inc. | 1986-10-31 |
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S001) | Sorin Biomedica, Fiat, USA, Inc. | 1986-08-26 |