FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URI-VAL
K Number: K843680
·
Decision Mar 29, 1985
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
1
Applicant Total
5
Review Days
192
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Basic Information
- Device Name
- URI-VAL
- K Number
- K843680
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1540
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cenogenics Corp.
- Date Received
- September 18, 1984
- Decision Date
- March 29, 1985
- Product Code
- JMZ
- 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 |
|---|---|---|---|
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMZ), ordered by most recent decision date.
View allOther Clearances by Cenogenics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K042641 | CHEMVIEW-10 | Jan 7, 2005 | Substantially Equivalent |
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | Apr 17, 2003 | Substantially Equivalent |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | Aug 26, 1999 | Substantially Equivalent |
| K894793 | MONODEX | Aug 21, 1989 | Substantially Equivalent |