Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4
FDA 510(k) K961807 · Ciba Corning Diagnostics Corp.
510(k) numberK961807
Submission
- Device name
- Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4
- Applicant
- Ciba Corning Diagnostics Corp.
Medfield, MA, US - Received
- May 10, 1996
- Decision date
- July 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLK – Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121467 | Eurotrol Hematocrit ControlGLK · Traditional | Eurotrol B.V. | 05/10/2013SE |
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | Bionostics, Inc. | 06/24/2002SE |
| K020618 | Aalto Scientific Mirco Hematocrit ControlGLK · Traditional | Aalto Scientific, Ltd. | 05/14/2002SE |
| K964452 | HematachekGLK · Traditional | Richmond Diagnostics, Inc. | 02/20/1997SE |
| K924926 | Msi-HctGLK · Traditional | Medical Specialties, Inc. | 01/07/1993SE |
| K893562 | A.Qc HCT Level 1 and 2GLK · Traditional | Johnson & Johnson Professionals, Inc. | 07/14/1989SE |
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| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | 12/13/1995SE |
Questions and answers
When was Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4 cleared by the FDA?
Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4 (K961807) received a 510(k) decision of Substantially Equivalent on July 26, 1996, 77 days after the submission was received.
What is the product code of K961807?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.