Coagulase Plasma-Citrated & Edta
FDA 510(k) K822988 · American Scientific Products
510(k) numberK822988
Submission
- Device name
- Coagulase Plasma-Citrated & Edta
- Applicant
- American Scientific Products
Mchenry, IL, US - Received
- October 12, 1982
- Decision date
- November 5, 1982
- 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 |
| 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 |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K831569 | Reagent CupsJJG · Traditional | 06/30/1983SE |
Questions and answers
When was Coagulase Plasma-Citrated & Edta cleared by the FDA?
Coagulase Plasma-Citrated & Edta (K822988) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 24 days after the submission was received.
What is the product code of K822988?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.