Trichomonas Broth (Kupforberg
FDA 510(k) K851599 · Preferred Micro-Media
510(k) numberK851599
Submission
- Device name
- Trichomonas Broth (Kupforberg
- Applicant
- Preferred Micro-Media
Toledo, OH, US - Received
- April 16, 1985
- Decision date
- May 8, 1985
- 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 |
|---|---|---|
| K851594 | SF BrothJSI · Traditional | 05/14/1985SE |
| K851597 | Triple Sugar Iron AgarJSH · Traditional | 05/13/1985SE |
| K851596 | Sim MediumJSH · Traditional | 05/13/1985SE |
| K851595 | Simmons Citrate AgarJSH · Traditional | 05/13/1985SE |
| K851593 | Selective Streptococcus AgarJSJ · Traditional | 05/13/1985SE |
| K851592 | Sabouraud Dextrose AgarJSJ · Traditional | 05/13/1985SE |
| K851591 | Phenylethyl Alcohol Agar W/5%SHEEP BloodJSJ · Traditional | 05/13/1985SE |
| K851598 | Thioglycollate Without IndicatorJSG · Traditional | 05/10/1985SE |
| K851576 | Biggy Agar Nickersons MediumJSH · Traditional | 05/09/1985SE |
| K851603 | Xylose Lysine Desoxycholate AgarJSI · Traditional | 05/08/1985SE |
Questions and answers
When was Trichomonas Broth (Kupforberg cleared by the FDA?
Trichomonas Broth (Kupforberg (K851599) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 22 days after the submission was received.
What is the product code of K851599?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.