FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DU PONT ANALYST THYROID ROTOR
K Number: K884169
·
Decision Jan 24, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
13
Review Days
112
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Basic Information
- Device Name
- DU PONT ANALYST THYROID ROTOR
- K Number
- K884169
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The DU Pont Co.
- Date Received
- October 4, 1988
- Decision Date
- January 24, 1989
- Product Code
- CEL
- 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 |
|---|---|---|---|
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEL), ordered by most recent decision date.
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAKO PHOSPHOLIPIDS TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by The DU Pont Co.
| K Number | Device Name | ||
|---|---|---|---|
| K953477 | MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING | Oct 7, 1995 | Substantially Equivalent |
| K953475 | CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING | Oct 7, 1995 | Substantially Equivalent |
| K952891 | CRONEX LOW ABSORPTION CASSETTE | Jul 13, 1995 | Substantially Equivalent |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | Mar 10, 1995 | Substantially Equivalent |
| K943704 | LIPASE CALIBRATOR | Sep 14, 1994 | Substantially Equivalent |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | Mar 20, 1990 | Substantially Equivalent |
| K885259 | ACA THYRONINE UPTAKE (TU E) METHOD | Feb 17, 1989 | Substantially Equivalent |
| K885258 | ACA THYROXINE (T4 E) METHOD | Feb 17, 1989 | Substantially Equivalent |
| K884700 | ANALYST THYROXINE (T4) ROTOR | Jan 27, 1989 | Substantially Equivalent |
| K884168 | ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. | Nov 29, 1988 | Substantially Equivalent |