AMNIOTEST(TM)
FDA 510(k) clearance K914419 · decided 1993-09-01
Clearance details
- K-number
- K914419
- Device name
- AMNIOTEST(TM)
- Applicant
- Pro-Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-03
- Decision date
- 1993-09-01
- Days to decision
- 699 days
- Clearance type
- Traditional
- Product code
- HIO
- Device class
- 1
- Regulation number
- 884.1550
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Ontario Canada M5m 1c9, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| G.E. STERILE AMNIOCENTESIS TRAY (K960203) | GE Medical Systems | 1996-03-14 |
| RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (K955679) | Contour Fabricators of Florida, Inc. | 1996-03-12 |
| VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960) | Cameo, Inc. | 1992-11-05 |
| SONO-VU US(TM), MODIFICATION (K921738) | E-Z-Em, Inc. | 1992-04-27 |
| MEGA AMNIOCENTESIS KIT (K915863) | Mega Medical, Inc. | 1992-03-30 |
| SONO-VU US(TM) (K904583) | E-Z-Em, Inc. | 1991-06-24 |
| ISOFLO(TM) AMNIOCENTESIS TRAY (K901643) | Healthdyne Cardiovascular, Inc. | 1990-07-25 |
| PERCU-SET(TM) (K900021) | E-Z-Em, Inc. | 1990-03-29 |
| AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (K896031) | Concord/Portex | 1990-01-12 |
| PHARMASEAL GENETIC AMNIOCENTESIS TRAY (K894031) | Baxter Healthcare Corp | 1989-08-04 |
| ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE (K892846) | Cook Ob/Gyn | 1989-07-14 |
| ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY (K890463) | Critical Specialties, Inc. | 1989-04-07 |
Recalls involving this device
No recalls on record reference this clearance.