PREPAX DILUKIT PLUS
FDA 510(k) clearance K840038 · decided 1984-02-10
Clearance details
- K-number
- K840038
- Device name
- PREPAX DILUKIT PLUS
- Applicant
- Scientific Distributors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-05
- Decision date
- 1984-02-10
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GIF
- Device class
- 1
- Regulation number
- 864.8200
- 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 |
|---|---|---|
| KVM ISOTONIC FLUSH SOLUTION (K883989) | Kvm Technologies, Inc. | 1988-10-12 |
| KVM ISOTONIC DILUENT (K883990) | Kvm Technologies, Inc. | 1988-10-12 |
| HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (K882490) | R&D Systems, Inc. | 1988-07-25 |
| SYSMEX QUICKLYSER-II (QLS-200A) (K882267) | Toa Medical Electronics USA, Inc. | 1988-07-12 |
| CELL-DYN ISOTONIC DILUENT (K881130) | Abbott Diagnostics | 1988-03-31 |
| CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (K873347) | Abbott Diagnostics | 1987-09-09 |
| OSMOCEL 3 (K851843) | Hematology Marketing Assoc. | 1985-07-30 |
| SDI PREPAX DILUKIT M. (K851320) | Scientific Distributors, Inc. | 1985-07-05 |
| DASS PACK (K851280) | Dass, Inc. | 1985-07-05 |
| SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (K850239) | Toa Medical Electronics USA, Inc. | 1985-04-01 |
| LASER-DIL (K850095) | Hematology Marketing Assoc. | 1985-03-29 |
| NSI ELT-D DILUTING FLUID 4000ML (K844782) | Nobel Scientific Industries, Inc. | 1985-03-05 |
Recalls involving this device
No recalls on record reference this clearance.