Penicillin-Streptomycin-Fungizone
FDA 510(k) K861791 · Flow Laboratories, Inc.
510(k) numberK861791
Submission
- Device name
- Penicillin-Streptomycin-Fungizone
- Applicant
- Flow Laboratories, Inc.
Mclean, VA, US - Received
- May 9, 1986
- Decision date
- May 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSK – Supplement, Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2450
- Specialty
- Microbiology
Other 510(k)s with product code JSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881949 | Ats Nac-Pac SetJSK · Traditional | Alpha-Tec Systems, Inc. | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| K881566 | Hemoglobin PowderJSK · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K861997 | Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional | Hazleton Research Products, Inc. | 06/10/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | Micro-Bio-Logics | 02/20/1986SE |
| K853546 | Abbott Cation Supplement SolutionJSK · Traditional | Abbott Laboratories | 09/06/1985SE |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
| K850738 | Supplement for Culture MediumJSK · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
More from Roseville Medical Laboratoriesu
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
| K844418 | Titertek Multiskan MCCJJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Penicillin-Streptomycin-Fungizone cleared by the FDA?
Penicillin-Streptomycin-Fungizone (K861791) received a 510(k) decision of Substantially Equivalent on May 20, 1986, 11 days after the submission was received.
What is the product code of K861791?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.