FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEKNI-CAL
K Number: K781601
·
Decision Oct 10, 1978
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
7
Applicant Total
70
Review Days
22
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Basic Information
- Device Name
- TEKNI-CAL
- K Number
- K781601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8175
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Streck Laboratories, Inc.
- Date Received
- September 18, 1978
- Decision Date
- October 10, 1978
- Product Code
- KRY
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRY | Calibrator For Platelet Counting | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRY), ordered by most recent decision date.
S-CAL HEMATOLOGY CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
LASER PLATELETCAL/MULTIPLE
FDA 510(k)
FDA Class 2
·Hematology
COULTER MEAN PLATELET VOLUME CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
S-CAL HEMATOLOGY CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
CONTROL DIAGNOSTICS PLATELET CONTROL
FDA 510(k)
FDA Class 2
·Hematology
PC-CALIBRATOR
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Streck Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042587 | RETIC-CHEX FOR CELL-DYN | Oct 19, 2004 | Substantially Equivalent |
| K040107 | CYTO-CHEX BCT | Jul 27, 2004 | Substantially Equivalent |
| K040025 | A1C-CELLULAR | Mar 2, 2004 | Substantially Equivalent |
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Dec 30, 2002 | Substantially Equivalent |
| K021922 | MODIFICATION TO PARA 5X | Jun 25, 2002 | Substantially Equivalent |
| K020469 | CAL-CHEX CD PLUS | Apr 4, 2002 | Substantially Equivalent |
| K013316 | SICKLE-CHEX | Nov 6, 2001 | Substantially Equivalent |
| K011410 | PARA 5X | Jun 26, 2001 | Substantially Equivalent |
| K001443 | SUGAR CHEX ONE | Jun 29, 2000 | Substantially Equivalent |
| K000945 | PARA 12 PLUS RETICS | Apr 18, 2000 | Substantially Equivalent |