Liquichek Immunology Control (Human) Levels I & II
FDA 510(k) K865014 · Bio-Rad
510(k) numberK865014
Submission
- Device name
- Liquichek Immunology Control (Human) Levels I & II
- Applicant
- Bio-Rad
Richmond, CA, US - Received
- December 23, 1986
- Decision date
- January 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGR – Whole Human Serum, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5700
- Specialty
- Immunology
Other 510(k)s with product code DGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961544 | Qualitrol Igame Controls, Levels 1 and 2DGR · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
| K902220 | Precipath(R) Im Normal & Abnormal Immuno. ControlDGR · Traditional | Boehringer Mannheim Corp. | 09/05/1990SE |
| K790298 | Radioassay, Control Serum I, II, IIIDGR · Traditional | Kallestad Laboratories, Inc. | 04/04/1979SE |
| K781355 | Ics Normal Control SerumDGR · Traditional | Beckman Instruments, Inc. | 08/31/1978SE |
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Questions and answers
When was Liquichek Immunology Control (Human) Levels I & II cleared by the FDA?
Liquichek Immunology Control (Human) Levels I & II (K865014) received a 510(k) decision of Substantially Equivalent on January 9, 1987, 17 days after the submission was received.
What is the product code of K865014?
The FDA product code is DGR – Whole Human Serum, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.