FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
K Number: K941219
·
Decision Aug 9, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
28
Review Days
148
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Basic Information
- Device Name
- DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
- K Number
- K941219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupont Medical Products
- Date Received
- March 14, 1994
- Decision Date
- August 9, 1994
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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Other Clearances by Dupont Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K952815 | DUPONT LIPASE CALIBRATOR | Aug 31, 1995 | Substantially Equivalent |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Aug 11, 1995 | Substantially Equivalent |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Jul 20, 1995 | Substantially Equivalent |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | Jun 23, 1995 | Substantially Equivalent |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | Mar 9, 1995 | Substantially Equivalent |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dec 28, 1994 | Substantially Equivalent |
| K941050 | DUPONT ACA STAR | Nov 10, 1994 | Substantially Equivalent |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Oct 20, 1994 | Substantially Equivalent |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Oct 3, 1994 | Substantially Equivalent |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Sep 9, 1994 | Substantially Equivalent |