Tissue-Tek III Accu-Cut Rotary Microtome
FDA 510(k) K812558 · Miles Laboratories, Inc.
510(k) numberK812558
Submission
- Device name
- Tissue-Tek III Accu-Cut Rotary Microtome
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- September 8, 1981
- Decision date
- September 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864733 | LKB 2260 MacrotomeIDO · Traditional | Lkb Instruments, Inc. | 01/05/1987SE |
| K863548 | Rotary MicrotomeIDO · Traditional | Surgipath Medical Industries, Inc. | 09/19/1986SE |
| K843505 | LKB 2230 Rotary OneIDO · Traditional | Lkb Instruments, Inc. | 11/30/1984SE |
| K812157 | Lkb-Bromma 2218 Historange MicrotomeIDO · Traditional | Lkb Instruments, Inc. | 08/18/1981SE |
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| 510(k) | Device | Decision |
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| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
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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 Tissue-Tek III Accu-Cut Rotary Microtome cleared by the FDA?
Tissue-Tek III Accu-Cut Rotary Microtome (K812558) received a 510(k) decision of Substantially Equivalent on September 29, 1981, 21 days after the submission was received.
What is the product code of K812558?
The FDA product code is IDO – Microtome, Rotary, a Class I (low risk) device regulated under 21 CFR 864.3010.