Product code JCG
- Device name
- Fluid, Diluting, Manual Cell
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.8200
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892658 | SDI PREPAX COUNTAPETTE KIT | Scientific Distributors, Inc. | 1989-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04061609000026 | Sperm-TIC 1:20 plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000248 | Reti-TIC | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000255 | Brillant Cresyl Blue Solution Isotonic | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000262 | Reti-TIC | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000279 | Eos-Count | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000286 | Eos-TIC 1:32 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000293 | Eos-TIC 1:32 plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000019 | Sperm-TIC 1:20 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000040 | Ejaculate-TIC 1:20 plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000033 | Ejaculate-TIC 1:20 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-13 |
| 04061609000309 | Erythrocyte Fragility (osmotic) | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000231 | Thrombo-TIC 1:100 pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000224 | ThromboCount pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000217 | ThromboCount pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000200 | Thrombo-TIC 1:100 pur plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000194 | Thrombo-TIC 1:100 pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000187 | Leuko-TIC 1:20 blau | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000170 | LeukoCount blau | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000163 | LeukoCount blau | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000156 | Leuko-TIC 1:20 blau plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000149 | Leuko-TIC 1:20 blau | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000132 | Ery-TIC 1:200 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000125 | EryCount pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000118 | EryCount pur | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000101 | Ery-TIC 1:200 plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000095 | Ery-TIC 1:200 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000088 | Leuko-TIC SF 1:100 plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000071 | Leuko-TIC SF 1:100 | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000064 | Leuko-TIC VT plus | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |
| 04061609000057 | Leuko-TIC VT | BIOANALYTIC GmbH, biomed. Analysentechnik | 2018-02-06 |