SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
FDA 510(k) clearance K892522 · decided 1989-05-24
Clearance details
- K-number
- K892522
- Device name
- SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
- Applicant
- Gespac, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-11
- Decision date
- 1989-05-24
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GKB
- Device class
- 1
- Regulation number
- 864.5800
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mesa, AZ, 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 |
|---|---|---|
| SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (K890503) | Gespac, Inc. | 1989-02-10 |
Recalls involving this device
No recalls on record reference this clearance.