FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIA-PACK IRI
K Number: K903628
·
Decision Sep 7, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
11
Review Days
28
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
- AIA-PACK IRI
- K Number
- K903628
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tosoh Corp.
- Date Received
- August 10, 1990
- Decision Date
- September 7, 1990
- Product Code
- CFP
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFP), ordered by most recent decision date.
ALPCO/MERCODIA INSULIN ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ULTRASENSITIVE INSULIN ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMX INSULIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL INSULIN RIA (DSL 1600)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENZYMUN TEST(R) INSULIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REP(TM) SPE PLUS-30 PROCEDURES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Tosoh Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023240 | ST AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K023239 | AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jul 21, 1992 | Substantially Equivalent |
| K913663 | AIA-PACK T-U | Sep 30, 1991 | Substantially Equivalent |
| K913298 | AIA-PACK CK-MB | Sep 27, 1991 | Substantially Equivalent |
| K913493 | AIA-PACK FT4 | Sep 10, 1991 | Substantially Equivalent |
| K901965 | MPR-4A - MICRO-PLATE READER | May 10, 1990 | Substantially Equivalent |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 2, 1990 | Substantially Equivalent |
| K897001 | TOSOH AIA-PACK T3 | Mar 9, 1990 | Substantially Equivalent |
| K896982 | AIA-PACK T4 | Mar 9, 1990 | Substantially Equivalent |