Tissue-Tek V.I.P. 100/200
FDA 510(k) K831313 · Miles Laboratories, Inc.
510(k) numberK831313
Submission
- Device name
- Tissue-Tek V.I.P. 100/200
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- April 22, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 12/29/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | Innovative Medical Systems, Inc. | 09/02/1988SE |
| K881165 | Sakura HEM-480 Electron Microscopy ProcessorIEO · Traditional | Sakura Finetek U.S.A., Inc. | 07/01/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 10/10/1985SE |
| K851054 | LX120 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 05/15/1985SE |
| K843506 | LKB 2189 UltroprocessorIEO · Traditional | Lkb Instruments, Inc. | 11/30/1984SE |
| K834599 | Autotechnicon V Tissue Process SysIEO · Traditional | Technicon Instruments Corp. | 02/04/1984SE |
| K801513 | Tissue Processing SystemIEO · Traditional | Innovative Medical Systems, Inc. | 07/28/1980SE |
| K801427 | Tissue-Tek III Mini-Rapid ProcessorIEO · Traditional | Miles Laboratories, Inc. | 07/28/1980SE |
| K771308 | Tissue-Tek III V.I.P.IEO · Traditional | Miles Laboratories, Inc. | 08/22/1977SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| 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 Tissue-Tek V.I.P. 100/200 cleared by the FDA?
Tissue-Tek V.I.P. 100/200 (K831313) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 97 days after the submission was received.
What is the product code of K831313?
The FDA product code is IEO – Processor, Tissue, Automated, a Class I (low risk) device regulated under 21 CFR 864.3875.