FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LABOTECH AUTOMATED MICROTITER ANALYZER
K Number: K922081
·
Decision Sep 2, 1992
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
22
Review Days
120
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
- LABOTECH AUTOMATED MICROTITER ANALYZER
- K Number
- K922081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- May 5, 1992
- Decision Date
- September 2, 1992
- 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 Innovative Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973035 | VIOLA II DENTAL CAMERA SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K951469 | BAZOOKA SYSTEM | Jun 28, 1995 | Substantially Equivalent |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | Nov 28, 1994 | Substantially Equivalent |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Dec 29, 1992 | Substantially Equivalent |
| K921005 | AUTOLOADER | Apr 29, 1992 | Substantially Equivalent |
| K915457 | PHACO 20/20 SYSTEM I | Feb 24, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent |