Oxoid Signal Blood Culture System
FDA 510(k) K862946 · Oxoid U.S.A., Inc.
510(k) numberK862946
Submission
- Device name
- Oxoid Signal Blood Culture System
- Applicant
- Oxoid U.S.A., Inc.
Hampshire Rg 24 Op, GB - Received
- August 5, 1986
- Decision date
- November 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSG – Culture Media, Non-Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2300
- Specialty
- Microbiology
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|---|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | Lakewood Biochemical Co., Inc. | 07/01/1988SE |
| K881564 | Tryptose Blood Agar Base W/Yeast ExtractJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881563 | Tryptose Phosphate BrothJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881562 | Tryptose Blood Agar BaseJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881558 | Tryptose AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881557 | TryptoneJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881554 | Skim Milk DehydratedJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881550 | Of Basal MediumJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881548 | MPH AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881546 | Malt Extract AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, 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 |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| 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 Oxoid Signal Blood Culture System cleared by the FDA?
Oxoid Signal Blood Culture System (K862946) received a 510(k) decision of Substantially Equivalent on November 5, 1986, 92 days after the submission was received.
What is the product code of K862946?
The FDA product code is JSG – Culture Media, Non-Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2300.