Spordex Culture Media
FDA 510(k) K850143 · American Sterilizer Co.
510(k) numberK850143
Submission
- Device name
- Spordex Culture Media
- Applicant
- American Sterilizer Co.
Erie, PA, US - Received
- January 14, 1985
- Decision date
- March 5, 1985
- 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
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|---|---|---|---|
| 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 |
| K830437 | CHSJSC · Traditional | Dms Laboratories | 03/17/1983SE |
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| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
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Questions and answers
When was Spordex Culture Media cleared by the FDA?
Spordex Culture Media (K850143) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 50 days after the submission was received.
What is the product code of K850143?
The FDA product code is JSC – Culture Media, General Nutrient Broth, a Class I (low risk) device regulated under 21 CFR 866.2350.