Specimen Collector
FDA 510(k) K770112 · Portex, Inc.
510(k) numberK770112
Submission
- Device name
- Specimen Collector
- Applicant
- Portex, Inc.
Walker, MI, US - Received
- January 19, 1977
- Decision date
- March 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code FMH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | Tri-Tech, Inc. | 09/17/1990SE |
| K823763 | Various-Specimen CollectorsFMH · Traditional | Cordis Corp. | 01/19/1983SE |
| K820180 | Calculi Filter CupFMH · Traditional | Omnimedical | 02/05/1982SE |
| K812933 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 11/06/1981SE |
| K802340 | Specimen SetFMH · Traditional | American Pharmaseal Div. Ahsc | 10/10/1980SE |
| K802002 | Urine Specimen Container #'S 1013-1016FMH · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K800947 | Midstream Collection KitFMH · Traditional | Sage Products, Inc. | 05/30/1980SE |
| K800309 | Specimen Collection PanFMH · Traditional | Sage Products, Inc. | 02/26/1980SE |
| K800233 | Abco Midstream Urine Collection SetFMH · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K792710 | Para-Pak Clean VialFMH · Traditional | Meridian Diagnostics, Inc. | 01/28/1980SE |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterCAZ · Traditional | 03/10/2004SE |
| K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…JOH · Traditional | 02/13/2004SE |
| K032112 | P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed)BTR · Traditional | 01/26/2004SE |
| K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterMQF · Traditional | 12/19/2003SE |
| K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)CAH · Traditional | 11/28/2003SE |
| K030570 | Blue Line Ultra Suctionaid Tracheostomy TubeBTO · Traditional | 09/17/2003SE |
| K030381 | Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaBTO · Traditional | 08/27/2003SE |
| K031057 | Per-Fit Percutaneous Dilational Tracheostomy KitJOH · Traditional | 07/18/2003SE |
| K031622 | Wallace Dual Lumen Oocyte Retrieval SetsMQE · Traditional | 06/26/2003SE |
| K023793 | 1ST Response Intermediate Manual ResuscitatorBTM · Traditional | 02/11/2003SE |
Questions and answers
When was Specimen Collector cleared by the FDA?
Specimen Collector (K770112) received a 510(k) decision of Substantially Equivalent on March 14, 1977, 54 days after the submission was received.
What is the product code of K770112?
The FDA product code is FMH – Container, Specimen, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.