510(k) K843619
- Device
- Retic-set
- Applicant
- R & D SYSTEMS, INC.
- 510(k) number
- K843619
- Product code
- KQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-30
- Date received
- 1984-09-14
- Regulation
- 864.1850
- Classification name
- Stains, Hematology
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE A CHRISTENSEN
- Address
- 614 Mckinley Pl. NE Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 9610140
- 3009547954
- 3005626422
- 3016090200
- 3009963993
- 2518071
- 3002805583
- 1045125
- 3009000266
- 3005592623
- 3000148879
- 3013058950
- 3010421384
- 1640981
- 2024375
- 3014053517
- 3008311438
- 9613959
- 2247035
- 3021584593
- 3010188738
- 1061932
- 3017970519
- 1831638
- 1029182
- 3007496191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KQC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Anatech, Ltd. | 1988-07-28 |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Warner-Lambert Co. | 1985-08-13 |
| K841848 | RETIC-SET | R&D Systems, Inc. | 1984-05-31 |
| K792550 | PONCEAU S STAIN SET | Electrophoresis Corp. of America | 1980-01-16 |
| K792496 | VOLU-SOL NMB RETICULOCYTE STAIN | Volu Sol Medical Industries | 1979-12-31 |
| K791007 | STAT DIFF STAIN | Bioscientific | 1979-08-03 |
| K760485 | HEMASTAIN FIXATIVE | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| K760487 | HEMASTAIN PHOSPHATE BUFFER | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |