Ics Normal Control Serum
FDA 510(k) K781355 · Beckman Instruments, Inc.
510(k) numberK781355
Submission
- Device name
- Ics Normal Control Serum
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- August 7, 1978
- Decision date
- August 31, 1978
- 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 |
| K865014 | Liquichek Immunology Control (Human) Levels I & IIDGR · Traditional | Bio-Rad | 01/09/1987SE |
| K790298 | Radioassay, Control Serum I, II, IIIDGR · Traditional | Kallestad Laboratories, Inc. | 04/04/1979SE |
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Questions and answers
When was Ics Normal Control Serum cleared by the FDA?
Ics Normal Control Serum (K781355) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 24 days after the submission was received.
What is the product code of K781355?
The FDA product code is DGR – Whole Human Serum, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.