510(k) K771580
- Device
- TEKTALLY II
- Applicant
- Scientific Products
- 510(k) number
- K771580
- Product code
- GKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-02
- Date received
- 1977-08-18
- Regulation
- 864.6160
- Classification name
- Hand-Tally, Differential
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2249760
- 3010194621
- 3006697110
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Coulter Electronics, Inc. | 1988-01-19 |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Future Impex Corp. | 1986-04-04 |
| K841026 | MANUAL BLOOD CELL COUNTING DEVICE | Instrumentation Laboratory CO | 1984-04-04 |