SPECTRASCAN
FDA 510(k) clearance K781103 · decided 1978-09-27
Clearance details
- K-number
- K781103
- Device name
- SPECTRASCAN
- Applicant
- Medishield, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-03
- Decision date
- 1978-09-27
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DAT
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM (K924892) | Organon Teknika Corp. | 1994-04-21 |
Recalls involving this device
No recalls on record reference this clearance.