LIQUID AST (SGOT)REAGENT SET
FDA 510(k) clearance K941132 · decided 1994-05-02
Clearance details
- K-number
- K941132
- Device name
- LIQUID AST (SGOT)REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1994-03-09
- Decision date
- 1994-05-02
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- CIT
- Device class
- 2
- Regulation number
- 862.1100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plas recall (Z-2116-2017) | Medtest Holdings, Inc. | 2017-05-18 |
| Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 recall (Z-0171-2009) | Pointe Scientific, Inc. | 2008-10-22 |
| AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. recall (Z-0172-2009) | Pointe Scientific, Inc. | 2008-10-22 |