Multi-Gram Developing Tank R-12 & R-3
FDA 510(k) K812919 · Marion Laboratories, Inc.
510(k) numberK812919
Submission
- Device name
- Multi-Gram Developing Tank R-12 & R-3
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- November 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKK – Tanks, Developing, Tlc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2270
- Specialty
- Clinical Chemistry
More from Marion Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Multi-Gram Developing Tank R-12 & R-3 cleared by the FDA?
Multi-Gram Developing Tank R-12 & R-3 (K812919) received a 510(k) decision of Substantially Equivalent on November 2, 1981, 14 days after the submission was received.
What is the product code of K812919?
The FDA product code is DKK – Tanks, Developing, Tlc, a Class I (low risk) device regulated under 21 CFR 862.2270.