Cultrol-Antibiotic/Antimycotic Solut
FDA 510(k) K834115 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK834115
Submission
- Device name
- Cultrol-Antibiotic/Antimycotic Solut
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Mchenry, IL, US - Received
- November 29, 1983
- Decision date
- March 23, 1984
- 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 |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
More from Pro-Lab, Inc.
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| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
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| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K855034 | American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional | 03/11/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | 08/03/1984SE |
Questions and answers
When was Cultrol-Antibiotic/Antimycotic Solut cleared by the FDA?
Cultrol-Antibiotic/Antimycotic Solut (K834115) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 115 days after the submission was received.
What is the product code of K834115?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.