Haemophilus Isolation Agar 2827
FDA 510(k) K841673 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK841673
Submission
- Device name
- Haemophilus Isolation Agar 2827
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Mchenry, IL, US - Received
- April 23, 1984
- Decision date
- May 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871855 | Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormJSH · Traditional | 05/26/1987SE |
| K871541 | Martin-Lewis Agar W/Reduced Vancomycin C0226JTY · Traditional | 04/29/1987SE |
| K870134 | Mcbride Listeria Agar W/Cycloheximide, Dri & PreJSJ · Traditional | 02/04/1987SE |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-FormJSJ · Traditional | 01/05/1987SE |
| K864014 | Lombard Dowell Agar BaseKZI · Traditional | 10/29/1986SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
| K861058 | Sensititre Auto Id Plate, AP70JTO · Traditional | 05/20/1986SE |
Questions and answers
When was Haemophilus Isolation Agar 2827 cleared by the FDA?
Haemophilus Isolation Agar 2827 (K841673) received a 510(k) decision of Substantially Equivalent on May 21, 1984, 28 days after the submission was received.
What is the product code of K841673?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.