Azlin Azlocilin Sodium-Diag. Reagent
FDA 510(k) K830758 · Miles Laboratories, Inc.
510(k) numberK830758
Submission
- Device name
- Azlin Azlocilin Sodium-Diag. Reagent
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- March 10, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTT – Susceptibility Test Powders, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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|---|---|---|---|
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | Accumed Intl., Inc. | 12/17/1998SE |
| K935805 | Pasco Mic and Mic/Id PanelsJTT · Traditional | Pasco Laboratories, Inc. | 06/13/1994SE |
| K895362 | Bactec Pyrazinamide Susceptibility TestJTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/01/1989SE |
| K880574 | Modified Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 05/04/1988SE |
| K872081 | Cipro (TM) Diagnostic PowderJTT · Traditional | Miles Pharmaceuticals | 06/15/1987SE |
| K864442 | Norfloxacin Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 12/11/1986SE |
| K860031 | Gen Diagnostics' Imipenem 10 MCG Susceptibity DiskJTT · Traditional | Organon Teknika Corp. | 03/06/1986SE |
| K855207 | Imipenem 10 MCG Sensitivity DiscsJTT · Traditional | Difco Laboratories, Inc. | 03/06/1986SE |
| K855106 | Imipenem 10 MCG Sensi-Disc,Cat. # 31644/31645JTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/06/1986SE |
| K855071 | Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 03/06/1986SE |
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| 510(k) | Device | Decision |
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| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Azlin Azlocilin Sodium-Diag. Reagent cleared by the FDA?
Azlin Azlocilin Sodium-Diag. Reagent (K830758) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 76 days after the submission was received.
What is the product code of K830758?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.