FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
AMNIOTEST(TM)
K Number: K914419
·
Decision Sep 1, 1993
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
27
Review Days
699
Basic Information
- Device Name
- AMNIOTEST(TM)
- K Number
- K914419
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRO-LAB, INC.
- Date Received
- October 3, 1991
- Decision Date
- September 1, 1993
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIO), ordered by most recent decision date.
G.E. STERILE AMNIOCENTESIS TRAY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SONO-VU US(TM), MODIFICATION
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SONO-VU US(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by PRO-LAB, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | Jan 27, 1995 | Substantially Equivalent |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Jul 28, 1992 | Substantially Equivalent |
| K903714 | E. COLI 0157 LATEX TEST | Jan 24, 1991 | Substantially Equivalent |
| K894221 | ROSCO PYRR | Sep 28, 1989 | Substantially Equivalent |
| K883995 | X-ACT UREA/TDA | Oct 12, 1988 | Substantially Equivalent |
| K883996 | X-ACT LDC/IND | Oct 12, 1988 | Substantially Equivalent |
| K871121 | PROTECT T.M. | Apr 14, 1987 | Substantially Equivalent |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 | Substantially Equivalent |
| K861142 | MASTER KIT B | Jul 10, 1986 | Unknown |
| K861888 | HIPPURATE HYDROLYSIS TEST | Jun 3, 1986 | Substantially Equivalent |