FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOVATION DIGITAL URINOMETER
K Number: K790862
·
Decision Jun 28, 1979
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
11
Review Days
52
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Basic Information
- Device Name
- BIOVATION DIGITAL URINOMETER
- K Number
- K790862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2800
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biovation, Inc.
- Date Received
- May 7, 1979
- Decision Date
- June 28, 1979
- Product Code
- JRE
- 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 |
|---|---|---|---|
| JRE | Refractometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRE), ordered by most recent decision date.
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Other Clearances by Biovation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925528 | BIOVATION K-MANAGER | Feb 5, 1993 | Substantially Equivalent |
| K923844 | LYRIS 100/120 LABORATORY INFORMATION SYSTEM | Dec 11, 1992 | Substantially Equivalent |
| K915071 | DIFFERENTIAL COUNTING BOARD | Jan 17, 1992 | Substantially Equivalent |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Aug 2, 1985 | Substantially Equivalent |
| K842401 | CHEMISTRY CONSOLE | Sep 4, 1984 | Substantially Equivalent |
| K831830 | LYRIS MODULAR INFO SYSTEM | Jun 25, 1984 | Substantially Equivalent |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | Jun 10, 1982 | Substantially Equivalent |
| K812604 | BIOVATION URINALYSIS REPORTER | Oct 2, 1981 | Substantially Equivalent |
| K792045 | BIOVATION NEPHELOMETER | Oct 30, 1979 | Substantially Equivalent |
| K781644 | ANTIBIOTIC NEPHELOMETER | Oct 3, 1978 | Substantially Equivalent |