Lombard-Dowell Broth Medium
FDA 510(k) K790619 · Anaerobe Systems
510(k) numberK790619
Submission
- Device name
- Lombard-Dowell Broth Medium
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 29, 1979
- Decision date
- April 23, 1979
- 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 |
|---|---|---|
| K844383 | Kanamycin 1000 MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844382 | Vancomycin 5MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844381 | Colistin 10 Mcg. Differential DiskJTO · Traditional | 01/04/1985SE |
| K844380 | Bile Differential DiskJTO · Traditional | 01/04/1985SE |
| K841303 | Campylobacter Thioglycollate MedJSG · Traditional | 04/17/1984SE |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | 04/05/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | 04/04/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | 04/04/1984SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | 04/04/1984SE |
Questions and answers
When was Lombard-Dowell Broth Medium cleared by the FDA?
Lombard-Dowell Broth Medium (K790619) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 25 days after the submission was received.
What is the product code of K790619?
The FDA product code is JSC – Culture Media, General Nutrient Broth, a Class I (low risk) device regulated under 21 CFR 866.2350.