SPORTROL RAPID STERILITY INDICATOR
FDA 510(k) clearance K962649 · decided 1997-09-26
Clearance details
- K-number
- K962649
- Device name
- SPORTROL RAPID STERILITY INDICATOR
- Applicant
- North American Science Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-08
- Decision date
- 1997-09-26
- Days to decision
- 445 days
- Clearance type
- Traditional
- Product code
- MTC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northwood, OH, US
- Third-party review
- No
- Expedited review
- No
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| Instant 20s Indicator (K210481) | True Indicating, LLC | 2021-12-14 |
Recalls involving this device
No recalls on record reference this clearance.