Dryslide Coagulase
FDA 510(k) K950706 · Difco Laboratories, Inc.
510(k) numberK950706
Submission
- Device name
- Dryslide Coagulase
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- February 15, 1995
- Decision date
- May 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTL – Plasma, Coagulase, Human, Horse And Rabbit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2160
- Specialty
- Microbiology
Other 510(k)s with product code JTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | Immuno-Mycologics, Inc. | 08/25/1988SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | Oxoid U.S.A., Inc. | 06/10/1987SE |
| K861312 | Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional | Micro-Bio-Logics | 04/18/1986SE |
| K840553 | HemastaphJTL · Traditional | Remel Co. | 04/13/1984SE |
| K833988 | Api Staphase IIIJTL · Traditional | Analytical Products, Inc. | 12/22/1983SE |
| K833858 | Coagulase Plasma, Horse & Rabbit EdtaJTL · Traditional | Otisville Biotech, Inc. | 12/08/1983SE |
| K822988 | Coagulase Plasma-Citrated & EdtaJTL · Traditional | American Scientific Products | 11/05/1982SE |
| K820177 | Coagulase PlasmaJTL · Traditional | Quadroma, Inc. | 02/05/1982SE |
| K812602 | Rabbit Coagulase PlasmaJTL · Traditional | Dutchland Laboratories, Inc. | 09/29/1981SE |
| K811982 | Staphase*JTL · Traditional | Analytical Products, Inc. | 07/28/1981SE |
More from Analytical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971211 | Dispens-O-Disc SparfloxacinJTN · Traditional | 04/14/1997SE |
| K971120 | Dispens-O-Disc (TM) LevofloxacinJTN · Traditional | 04/14/1997SE |
| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | 09/26/1996SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
| K941016 | Dispens-O-Disc(Tm) NitrocefinJTO · Traditional | 06/30/1994SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | 02/22/1994SE |
Questions and answers
When was Dryslide Coagulase cleared by the FDA?
Dryslide Coagulase (K950706) received a 510(k) decision of Substantially Equivalent on May 16, 1995, 90 days after the submission was received.
What is the product code of K950706?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.