Rabbit Coagulase Plasma
FDA 510(k) K812602 · Dutchland Laboratories, Inc.
510(k) numberK812602
Submission
- Device name
- Rabbit Coagulase Plasma
- Applicant
- Dutchland Laboratories, Inc.
Mchenry, IL, US - Received
- September 15, 1981
- Decision date
- September 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K950706 | Dryslide CoagulaseJTL · Traditional | Difco Laboratories, Inc. | 05/16/1995SE |
| 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 |
| K811982 | Staphase*JTL · Traditional | Analytical Products, Inc. | 07/28/1981SE |
More from Analytical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821919 | Powdered RPMI-1634 MediumKIT · Traditional | 07/27/1982SE |
| K821918 | Powdered RPMI-1603 MediumKIT · Traditional | 07/27/1982SE |
| K821917 | Waymouth's Powder MediumKIT · Traditional | 07/27/1982SE |
| K821916 | Improved Mem-Richter's Powder Modif.KIT · Traditional | 07/27/1982SE |
| K821915 | Bme Autoclavable MediumKIT · Traditional | 07/27/1982SE |
| K821914 | Coon's F-12 Powder MediumKIT · Traditional | 07/27/1982SE |
| K821913 | Iscove's Modified Dulbecco Powder MediumKIT · Traditional | 07/27/1982SE |
| K821912 | Mccoy's Powder Medium 5A SuspensionKIT · Traditional | 07/27/1982SE |
| K821911 | S-Mem-Joklik's PowderKIT · Traditional | 07/27/1982SE |
| K820931 | Hank's 199 Powdered MediumKIT · Traditional | 04/21/1982SE |
Questions and answers
When was Rabbit Coagulase Plasma cleared by the FDA?
Rabbit Coagulase Plasma (K812602) received a 510(k) decision of Substantially Equivalent on September 29, 1981, 14 days after the submission was received.
What is the product code of K812602?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.