FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETIC-CHEX FOR CELL-DYN
K Number: K042587
·
Decision Oct 19, 2004
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
70
Review Days
27
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Basic Information
- Device Name
- RETIC-CHEX FOR CELL-DYN
- K Number
- K042587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck Laboratories, Inc.
- Date Received
- September 22, 2004
- Decision Date
- October 19, 2004
- Product Code
- JPK
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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Other Clearances by Streck Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K000115 | RETIC CHEX LINEARITY | Mar 27, 2000 | Substantially Equivalent |