LKB 4460 Fluorimeter
FDA 510(k) K811019 · Lkb Instruments, Inc.
510(k) numberK811019
Submission
- Device name
- LKB 4460 Fluorimeter
- Applicant
- Lkb Instruments, Inc.
Mchenry, IL, US - Received
- April 15, 1981
- Decision date
- April 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
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Questions and answers
When was LKB 4460 Fluorimeter cleared by the FDA?
LKB 4460 Fluorimeter (K811019) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 14 days after the submission was received.
What is the product code of K811019?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.