Culture Collec. Trans. Sys., Double Dry
FDA 510(k) K772209 · Precision Dynamics Corp.
510(k) numberK772209
Submission
- Device name
- Culture Collec. Trans. Sys., Double Dry
- Applicant
- Precision Dynamics Corp.
Mchenry, IL, US - Received
- December 1, 1977
- Decision date
- December 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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|---|---|---|---|
| K121039 | Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional | Copan Flock Technologies | 05/25/2012SE |
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 06/23/2006SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | Gen-Probe, Inc. | 09/17/2002SE |
| K013819 | Urine Collection, Preservation and Transport SystemJTW · Traditional | Sierra Diagnostic, LLC | 02/28/2002SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 11/09/1999SE |
| K983244 | Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional | Trek Diagnostic Systems, Inc. | 11/30/1998SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | Difco Laboratories, Inc. | 04/26/1996SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | Difco Laboratories, Inc. | 02/22/1994SE |
| K904773 | P and T MediumJTW · Traditional | Gibson Laboratories, Inc. | 12/04/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/24/1989SE |
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| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | 03/22/2000SE |
| K994263 | Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional | 01/24/2000SE |
| K990737 | 'Ecurline Umbilical Cord Clamp #3500HFW · Traditional | 04/06/1999SE |
| K884357 | Precision Bioport Collection & Transport SystemKOT · Traditional | 11/01/1988SE |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | 07/08/1988SE |
| K874665 | Securline Fine Needle Aspiration Biopsy TrayLRP · Traditional | 01/20/1988SESD |
| K873369 | Securline Franseene NeedleKNW · Traditional | 10/20/1987SE |
| K872507 | Precision Culture C.A.T.S. Collect/Trans HSV I/IiJSM · Traditional | 07/09/1987SE |
Questions and answers
When was Culture Collec. Trans. Sys., Double Dry cleared by the FDA?
Culture Collec. Trans. Sys., Double Dry (K772209) received a 510(k) decision of Substantially Equivalent on December 20, 1977, 19 days after the submission was received.
What is the product code of K772209?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.