FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
CLS 962 MICROPLATE PHOTOMETER
K Number: K891869
·
Decision May 9, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
4
Review Days
43
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
- CLS 962 MICROPLATE PHOTOMETER
- K Number
- K891869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Life Sciences Plc.
- Date Received
- March 27, 1989
- Decision Date
- May 9, 1989
- 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