510(k) K770143
- Device
- Tqc Calibration Reference For Platelets
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K770143
- Product code
- KRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-30
- Date received
- 1977-01-24
- Regulation
- 864.8175
- Classification name
- Calibrator For Platelet Counting
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1061932
- 3007603826
- 1950302
- 1064130
- 1064608
- 3014150341
- 2221819
- 3000148879
- 2182501
- 3016438761
- 3005333358
- 1017835
- 3003741796
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K862122 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1987-05-20 |
| K852016 | LASER PLATELETCAL/MULTIPLE | R&D Systems, Inc. | 1985-07-09 |
| K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR | Coulter Electronics, Inc. | 1985-01-07 |
| K840794 | S-CAL HEMATOLOGY CALIBRATOR | Coulter Electronics, Inc. | 1984-04-04 |
| K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL | Immunogenetics | 1982-09-02 |
| K781601 | TEKNI-CAL | Streck Laboratories, Inc. | 1978-10-10 |
| K781133 | PC-CALIBRATOR | Streck Laboratories, Inc. | 1978-08-14 |