PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
FDA 510(k) clearance K031114 · decided 2004-03-03
Clearance details
- K-number
- K031114
- Device name
- PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
- Applicant
- Raven Biological Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-08
- Decision date
- 2004-03-03
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- MRB
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Omaha, NE, 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.
| Record | Firm | Date |
|---|---|---|
| SPSMEDICAL SPORVIEW PA CULTURE SET (K081879) | Spsmedical Supply Corp. | 2008-07-30 |
| RAVEN PROPACT (K053212) | Raven Biological Laboratories, Inc. | 2006-02-15 |
| SPSMEDICAL SPORVIEW PA CULTURE SET (K043135) | Spsmedical Supply Corp. | 2005-01-13 |
Recalls involving this device
No recalls on record reference this clearance.