CHS
FDA 510(k) K830437 · Dms Laboratories
510(k) numberK830437
Submission
- Device name
- CHS
- Applicant
- Dms Laboratories
Mchenry, IL, US - Received
- February 9, 1983
- Decision date
- March 17, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSC – Culture Media, General Nutrient Broth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2350
- Specialty
- Microbiology
Other 510(k)s with product code JSC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K850143 | Spordex Culture MediaJSC · Traditional | American Sterilizer Co. | 03/05/1985SE |
| K842852 | Brain Heart Infusion BrothJSC · Traditional | Anarobe Systems | 08/03/1984SE |
| K842849 | Trypticase Soy BrothJSC · Traditional | Anarobe Systems | 08/03/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | Anaerobe Systems | 04/04/1984SE |
| K841219 | Shopped Meat CarbohydrateJSC · Traditional | Anaerobe Systems | 04/04/1984SE |
| K833300 | Sabouraud Bhi AgarJSC · Traditional | Acumedia Manufacturers, Inc. | 11/07/1983SE |
| K832620 | Tryptic Soy Broth MediaJSC · Traditional | Carroll Biological Corp. | 09/12/1983SE |
| K832619 | Thioglycollate MediumJSC · Traditional | Carroll Biological Corp. | 09/12/1983SE |
| K832570 | Extract BrothJSC · Traditional | Acumedia Manufacturers, Inc. | 09/12/1983SE |
| K832569 | Infusion BrothJSC · Traditional | Acumedia Manufacturers, Inc. | 09/12/1983SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K831187 | TRPJTO · Traditional | 05/09/1983SE |
| K831186 | Rapid NFTJSN · Traditional | 05/09/1983SE |
| K823102 | Agar PJSJ · Traditional | 12/03/1982SE |
| K821038 | Fast Violet BJTS · Traditional | 05/27/1982SE |
| K813613 | Rapid CHJTO · Traditional | 02/22/1982SE |
| K813612 | Rapid ZymeJTO · Traditional | 02/22/1982SE |
| K820213 | Saline SolutionJTO · Traditional | 02/12/1982SE |
| K820212 | OxiJTO · Traditional | 02/12/1982SE |
| K820211 | NinhydrinJTO · Traditional | 02/12/1982SE |
| K820210 | IndJTO · Traditional | 02/12/1982SE |
Questions and answers
When was CHS cleared by the FDA?
CHS (K830437) received a 510(k) decision of Substantially Equivalent on March 17, 1983, 36 days after the submission was received.
What is the product code of K830437?
The FDA product code is JSC – Culture Media, General Nutrient Broth, a Class I (low risk) device regulated under 21 CFR 866.2350.