FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORNING 760 FLUOROMETER/DENSITOMETER
K Number: K803240
·
Decision Jan 9, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
21
Review Days
17
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
- CORNING 760 FLUOROMETER/DENSITOMETER
- K Number
- K803240
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Transidyne General Corp.
- Date Received
- December 23, 1980
- Decision Date
- January 9, 1981
- Product Code
- JQT
- 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 |
|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQT), ordered by most recent decision date.
ASIMANAGER - AT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ISOSCAN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 795 FLUOROMETER/DENSITOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TARGET READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECTROPHORESIS DATA CENTER (EDC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ICON READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Transidyne General Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Jul 25, 1996 | Substantially Equivalent |
| K955658 | LACERATION TRAY | Jan 25, 1996 | Substantially Equivalent |
| K950773 | PROPHYLAXIS PACK | Mar 31, 1995 | Unknown |
| K950743 | ORAL PROCEDURE PACK | Mar 31, 1995 | Unknown |
| K950449 | SURGICAL BUR | Mar 1, 1995 | Substantially Equivalent |
| K950403 | SURGICAL SAW BLADES | Feb 21, 1995 | Substantially Equivalent |
| K924811 | I.V. START KIT | Jun 17, 1993 | Unknown |
| K924243 | TRACHEOSTOMY CARE KIT | Jun 16, 1993 | Unknown |
| K922339 | SUTURE REMOVAL KIT | Dec 11, 1992 | Unknown |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Nov 6, 1992 | Unknown |