Mucolyse
FDA 510(k) K850300 · Pro-Lab, Inc.
510(k) numberK850300
Submission
- Device name
- Mucolyse
- Applicant
- Pro-Lab, Inc.
Ontario Canada M5m 1c9, CA - Received
- January 22, 1985
- Decision date
- March 20, 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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| 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 |
| 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 |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
More from Pro-Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | 01/27/1995SE |
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
Questions and answers
When was Mucolyse cleared by the FDA?
Mucolyse (K850300) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 57 days after the submission was received.
What is the product code of K850300?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.