FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
K Number: K923917
·
Decision Feb 25, 1994
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
22
Review Days
569
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Basic Information
- Device Name
- ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
- K Number
- K923917
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nuclear Diagnostics, Inc.
- Date Received
- August 5, 1992
- Decision Date
- February 25, 1994
- 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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LIPASE-PS ASSAY PROCEDURE NO. 805
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Other Clearances by Nuclear Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 2, 1993 | Substantially Equivalent |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Jun 17, 1987 | Substantially Equivalent |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Sep 26, 1986 | Substantially Equivalent |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Jul 3, 1986 | Substantially Equivalent |
| K861735 | TIPSEP-TBG ASSAY | Jun 13, 1986 | Substantially Equivalent |
| K852291 | TIPSEP DIGOXIN RIA | Jun 25, 1985 | Substantially Equivalent |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Dec 29, 1983 | Substantially Equivalent |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Apr 18, 1983 | Substantially Equivalent |
| K811558 | TSH-P.E.G. | Jun 18, 1981 | Substantially Equivalent |
| K810906 | TRI-LEVEL NDI CONTROL | Apr 14, 1981 | Substantially Equivalent |