FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE ADVANCED OSMOMETER (3900)
K Number: K965036
·
Decision Feb 20, 1997
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
11
Applicant Total
16
Review Days
65
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
- THE ADVANCED OSMOMETER (3900)
- K Number
- K965036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Instruments, Inc.
- Date Received
- December 17, 1996
- Decision Date
- February 20, 1997
- Product Code
- JJM
- 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 |
|---|---|---|---|
| JJM | Osmometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJM), ordered by most recent decision date.
ADVANCED MICRO-OSMOMETER MODEL 3300
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 3D3 OSMOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OSMOMETER MODEL 2400
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OSMOMETER MODEL 110
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AO-10 AUTOMATED OSMOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OSMOTIC PRESSURE AUTO & STAT OM-6010
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Advanced Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | May 27, 2016 | Substantially Equivalent |
| K120631 | PATIENT MONITOR | May 25, 2012 | Substantially Equivalent |
| K112465 | VITAL SIGNS MONITOR | Sep 14, 2011 | Substantially Equivalent |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Jul 11, 1996 | Substantially Equivalent |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | Nov 18, 1993 | Substantially Equivalent |
| K925970 | MODEL 3D3 OSMOMETER | Jul 9, 1993 | Substantially Equivalent |
| K911092 | OSMOMETER MODEL 2400 | May 22, 1991 | Substantially Equivalent |
| K873642 | OSMOMETER MODEL 110 | Oct 20, 1987 | Substantially Equivalent |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | Sep 30, 1986 | Substantially Equivalent |
| K842784 | CEREGROTRAC | Jan 10, 1985 | Substantially Equivalent |