LKB 2230 Rotary One
FDA 510(k) K843505 · Lkb Instruments, Inc.
510(k) numberK843505
Submission
- Device name
- LKB 2230 Rotary One
- Applicant
- Lkb Instruments, Inc.
Gaithersburg, MD, US - Received
- September 6, 1984
- Decision date
- November 30, 1984
- 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 |
| K812558 | Tissue-Tek III Accu-Cut Rotary MicrotomeIDO · Traditional | Miles Laboratories, Inc. | 09/29/1981SE |
| K812157 | Lkb-Bromma 2218 Historange MicrotomeIDO · Traditional | Lkb Instruments, Inc. | 08/18/1981SE |
More from Lkb Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | 08/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was LKB 2230 Rotary One cleared by the FDA?
LKB 2230 Rotary One (K843505) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 85 days after the submission was received.
What is the product code of K843505?
The FDA product code is IDO – Microtome, Rotary, a Class I (low risk) device regulated under 21 CFR 864.3010.