FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED DELFIA ESTRADIOL KIT
K Number: K902358
·
Decision Jun 18, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
129
Review Days
20
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Basic Information
- Device Name
- MODIFIED DELFIA ESTRADIOL KIT
- K Number
- K902358
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- May 29, 1990
- Decision Date
- June 18, 1990
- Product Code
- CHP
- 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
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VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·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 |