Iafp Urea Agar Slant
FDA 510(k) K872691 · I.A.F. Production, Inc.
510(k) numberK872691
Submission
- Device name
- Iafp Urea Agar Slant
- Applicant
- I.A.F. Production, Inc.
Laval, Que. H7n-423, CA - Received
- July 7, 1987
- Decision date
- August 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSF – Culture Media, Single Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | Lakewood Biochemical Co., Inc. | 04/01/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880139 | Onpg Test ReagentJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880135 | Nitrate BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880129 | Brilliant Green Bile BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880118 | Moelloers Decarboxylase, ArginineJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880113 | Cystine Tryptic Medium W/LactoseJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880112 | Cystine Tryptic Medium W/ MaltoseJSF · Traditional | Hardy Media | 03/30/1988SE |
More from Hardy Media
| 510(k) | Device | Decision |
|---|---|---|
| K872690 | Iafp V. Agar SelectiveJSJ · Traditional | 09/14/1987SE |
| K872692 | Iafp P.E.A. Agar W/5% Sheep BloodJSJ · Traditional | 08/11/1987SE |
| K872689 | Iafp Sabouraud Dextrose AgarJSJ · Traditional | 08/11/1987SE |
| K872688 | Iafp Mueller Hinton Agar W/5% Sheep BloodLKA · Traditional | 08/11/1987SE |
| K872687 | Iafp Mueller Hinton Agar W/Hemo. W/Cva EnrichmentLKA · Traditional | 08/11/1987SE |
| K872686 | Iafp Mueller Hinton AgarLKA · Traditional | 08/11/1987SE |
| K872685 | Iafp Lowenstein Jensen SlantKZI · Traditional | 08/11/1987SE |
| K872684 | Iafp Campylobacter BlaserJSJ · Traditional | 08/11/1987SE |
| K872683 | Iafp Bile Esculin AgarJSI · Traditional | 08/11/1987SE |
| K872682 | Iafp S.S. AgarJSI · Traditional | 08/11/1987SE |
Questions and answers
When was Iafp Urea Agar Slant cleared by the FDA?
Iafp Urea Agar Slant (K872691) received a 510(k) decision of Substantially Equivalent on August 11, 1987, 35 days after the submission was received.
What is the product code of K872691?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.