CROSS-CHECKS P
FDA 510(k) clearance K972300 · decided 1998-03-25
Clearance details
- K-number
- K972300
- Device name
- CROSS-CHECKS P
- Applicant
- Steritec Products Mfg Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-19
- Decision date
- 1998-03-25
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Castle Rock, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205. recall (Z-1532-2010) | Steritec Products Mfc. Co., Inc. | 2010-04-29 |