REES & ECKER DILUTION FLUID
FDA 510(k) clearance K842921 · decided 1984-09-07
Clearance details
- K-number
- K842921
- Device name
- REES & ECKER DILUTION FLUID
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-25
- Decision date
- 1984-09-07
- Days to decision
- 44 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
+ Add to Predicate Builder ◉ Watch E K Ind.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LABTRONIX PLATELET COUNTER(L/O/C.) (K811084) | Labtronix Corp. | 1981-07-23 |
| PLATELET KIT (K772105) | Streck Laboratories, Inc. | 1977-11-30 |
Recalls involving this device
No recalls on record reference this clearance.