FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHADEBAS T3 U TEST
K Number: K771078
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
129
Review Days
12
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
- PHADEBAS T3 U TEST
- K Number
- K771078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- June 15, 1977
- Decision Date
- June 27, 1977
- Product Code
- KHQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHQ), ordered by most recent decision date.
ACE T UPTAKE REAGENT TU CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T-UPTAKE MICROPLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHIRON DIAGNOSTICS ACS:180TU P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS T-UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CEDIA T UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Pharmacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
| K972364 | UNICAP PHADIATOP | Sep 4, 1997 | Substantially Equivalent |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Jul 3, 1997 | Substantially Equivalent |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Jun 30, 1997 | Substantially Equivalent |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |