FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
K Number: K850995
·
Decision May 10, 1985
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
18
Review Days
60
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
- K Number
- K850995
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Awareness Technology, Inc.
- Date Received
- March 11, 1985
- Decision Date
- May 10, 1985
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJQ), ordered by most recent decision date.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIGENE DML 2000 MICROPLATE LUMINOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STAT TRACKS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANTHOS PHACTS VERSION MICROPLATE READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CBI 7520 READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Awareness Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Feb 27, 2018 | Substantially Equivalent |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Jul 19, 2002 | Substantially Equivalent |
| K010877 | CHEMWELL, MODEL 2900 | May 23, 2001 | Substantially Equivalent |
| K974762 | STAT TRACKS | Jan 28, 1998 | Substantially Equivalent |
| K943729 | DYE CHECK STRIPS 545-630 | Dec 29, 1994 | Substantially Equivalent |
| K941394 | STAT FAX 2600 | Jun 3, 1994 | Substantially Equivalent |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Oct 14, 1992 | Substantially Equivalent |
| K900224 | STAT FAX(TM)-2100 | Mar 1, 1990 | Substantially Equivalent |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | May 22, 1989 | Substantially Equivalent |
| K882938 | STAT FAX(TM) | Sep 9, 1988 | Substantially Equivalent |