Suplex & Suplex Diluent
FDA 510(k) K850302 · Pro-Lab, Inc.
510(k) numberK850302
Submission
- Device name
- Suplex & Suplex Diluent
- Applicant
- Pro-Lab, Inc.
Ontario Canada M5m 1c9, CA - Received
- January 22, 1985
- Decision date
- March 22, 1985
- 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
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| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · 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 |
| K850738 | Supplement for Culture MediumJSK · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
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| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
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| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
Questions and answers
When was Suplex & Suplex Diluent cleared by the FDA?
Suplex & Suplex Diluent (K850302) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 59 days after the submission was received.
What is the product code of K850302?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.