Arylsulfatase Broth
FDA 510(k) K871701 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK871701
Submission
- Device name
- Arylsulfatase Broth
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- May 1, 1987
- Decision date
- May 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
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Questions and answers
When was Arylsulfatase Broth cleared by the FDA?
Arylsulfatase Broth (K871701) received a 510(k) decision of Substantially Equivalent on May 20, 1987, 19 days after the submission was received.
What is the product code of K871701?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.