Iafp Mueller Hinton Agar
FDA 510(k) K872686 · I.A.F. Production, Inc.
510(k) numberK872686
Submission
- Device name
- Iafp Mueller Hinton Agar
- 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
- LKA – Culture Media, Antimicrobial Susceptibility Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Specialty
- Microbiology
Other 510(k)s with product code LKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872688 | Iafp Mueller Hinton Agar W/5% Sheep BloodLKA · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872687 | Iafp Mueller Hinton Agar W/Hemo. W/Cva EnrichmentLKA · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K833218 | Yeast Beef Agar-Antibiotic MED.4LKA · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833207 | Ak Agar 2LKA · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
More from Acumedia Manufacturers, Inc.
| 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 |
| K872691 | Iafp Urea Agar SlantJSF · 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 |
| 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 Mueller Hinton Agar cleared by the FDA?
Iafp Mueller Hinton Agar (K872686) 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 K872686?
The FDA product code is LKA – Culture Media, Antimicrobial Susceptibility Test, a Class II (moderate risk) device regulated under 21 CFR 866.1700.