SPSMEDICAL SPORVIEW PA CULTURE SET
FDA 510(k) clearance K043135 · decided 2005-01-13
Clearance details
- K-number
- K043135
- Device name
- SPSMEDICAL SPORVIEW PA CULTURE SET
- Applicant
- Spsmedical Supply Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-12
- Decision date
- 2005-01-13
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- MRB
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rush, NY, 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 |
| PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA (K031114) | Raven Biological Laboratories, Inc. | 2004-03-03 |
Recalls involving this device
No recalls on record reference this clearance.