LABTRONIX PLATELET COUNTER(L/O/C.)
FDA 510(k) clearance K811084 · decided 1981-07-23
Clearance details
- K-number
- K811084
- Device name
- LABTRONIX PLATELET COUNTER(L/O/C.)
- Applicant
- Labtronix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-21
- Decision date
- 1981-07-23
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- GLG
- Device class
- 1
- Regulation number
- 864.6160
- 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 |
|---|---|---|
| REES & ECKER DILUTION FLUID (K842921) | E K Ind., Inc. | 1984-09-07 |
| PLATELET KIT (K772105) | Streck Laboratories, Inc. | 1977-11-30 |
Recalls involving this device
No recalls on record reference this clearance.