FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K Number: K872177
·
Decision Jun 17, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
83
Applicant Total
22
Review Days
9
Basic Information
- Device Name
- TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
- K Number
- K872177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- NUCLEAR DIAGNOSTICS, INC.
- Date Received
- June 8, 1987
- Decision Date
- June 17, 1987
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
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Other Clearances by NUCLEAR DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Feb 25, 1994 | Substantially Equivalent |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 2, 1993 | 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 |