FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIPASE FLEX REAGENT CARTRIDGE
K Number: K952816
·
Decision Jul 20, 1995
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
28
Review Days
30
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Basic Information
- Device Name
- LIPASE FLEX REAGENT CARTRIDGE
- K Number
- K952816
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupont Medical Products
- Date Received
- June 20, 1995
- Decision Date
- July 20, 1995
- Product Code
- CHI
- 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 |
|---|---|---|---|
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHI), ordered by most recent decision date.
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
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SENTINEL LIPASE LIQUID MODEL 17.401B
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FDA Class 1
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CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
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IL TEST LIPASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIPASE-PS ASSAY PROCEDURE NO. 805
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| 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 |
| K942241 | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN | Aug 18, 1994 | Substantially Equivalent |