Qualitrol Igame Controls, Levels 1 and 2
FDA 510(k) K961544 · Consolidated Technologies, Inc.
510(k) numberK961544
Submission
- Device name
- Qualitrol Igame Controls, Levels 1 and 2
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- April 22, 1996
- Decision date
- September 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K781355 | Ics Normal Control SerumDGR · Traditional | Beckman Instruments, Inc. | 08/31/1978SE |
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| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
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Questions and answers
When was Qualitrol Igame Controls, Levels 1 and 2 cleared by the FDA?
Qualitrol Igame Controls, Levels 1 and 2 (K961544) received a 510(k) decision of Substantially Equivalent on September 24, 1996, 155 days after the submission was received.
What is the product code of K961544?
The FDA product code is DGR – Whole Human Serum, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.