510(k) K813530
- Device
- Hemotology Calibrator
- Applicant
- AMERICAN DADE
- 510(k) number
- K813530
- Product code
- KSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-22
- Date received
- 1981-12-17
- Regulation
- 864.8185
- Classification name
- Calibrator For Red-Cell And White-Cell Counting
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1064608
- 9613959
- 1061932
- 3007603826
- 2432235
- 3014150341
- 3016438761
- 2182501
- 3009711478
- 1064130
- 2221819
- 1950302
- 3000148879
- 3005333358
- 3003741796
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Streck Laboratories, Inc. | 1994-12-15 |
| K897060 | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | R&D Systems, Inc. | 1990-01-02 |
| K881161 | TECH-CAL(TM)/MULTIPLE | R&D Systems, Inc. | 1988-05-02 |
| K864664 | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Technicon Instruments Corp. | 1987-02-06 |
| K854823 | CBC-CAL/MULTIPLE | R&D Systems, Inc. | 1986-02-13 |
| K844708 | TRI-COUNT CALIBRATOR | Hematology Marketing Assoc. | 1985-03-05 |
| K813375 | HEMATOLOGY CALIBRATOR S-CAL | Coulter Electronics, Inc. | 1982-02-04 |