Rabbit Plasma Fibrinogen Supplement SR 122
FDA 510(k) K870945 · Oxoid U.S.A., Inc.
510(k) numberK870945
Submission
- Device name
- Rabbit Plasma Fibrinogen Supplement SR 122
- Applicant
- Oxoid U.S.A., Inc.
Columbia, MD, US - Received
- March 9, 1987
- Decision date
- June 10, 1987
- 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 |
| 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 |
|---|---|---|
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | 06/09/1989SE |
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | 02/03/1989SE |
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | 10/25/1988SE |
| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
| K855234 | Diagnostic Reagent Vet-RplaGNA · Traditional | 11/04/1986SE |
Questions and answers
When was Rabbit Plasma Fibrinogen Supplement SR 122 cleared by the FDA?
Rabbit Plasma Fibrinogen Supplement SR 122 (K870945) received a 510(k) decision of Substantially Equivalent on June 10, 1987, 93 days after the submission was received.
What is the product code of K870945?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.