FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCUVETTE II
K Number: K760197
·
Decision Jul 19, 1976
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
101
Review Days
13
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Basic Information
- Device Name
- ACCUVETTE II
- K Number
- K760197
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- July 6, 1976
- Decision Date
- July 19, 1976
- Product Code
- JRI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JRI | Cuvette, Thermostated | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRI), ordered by most recent decision date.
MEDATRON CUVETTE DISC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMO SET ELECTRONIC TEM. CONTROLLER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TEMPERATURE REGULATED FIVE CELL HOLDERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Coulter Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Apr 25, 1994 | Substantially Equivalent |
| K930119 | COULTER RETIC-C CELL CONTROL | Apr 5, 1993 | Substantially Equivalent |
| K921279 | CD4 CYTOSPHERES KIT | Dec 29, 1992 | Substantially Equivalent |
| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905771 | COULTER DART AST (GOT) REAGENT | Feb 26, 1991 | Substantially Equivalent |