Blood Grouping Sys., BG-9
FDA 510(k) K771098 · Technicon Instruments Corp.
510(k) numberK771098
Submission
- Device name
- Blood Grouping Sys., BG-9
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- June 20, 1977
- Decision date
- August 4, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSZ – System, Test, Automated Blood Grouping And Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9175
- Specialty
- Hematology
Other 510(k)s with product code KSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810899 | Technicon Autogrouper 16-C SystemKSZ · Traditional | Technicon Instruments Corp. | 05/05/1981SE |
| K790282 | EldoncardKSZ · Traditional | Nordisk Infuser System | 05/04/1979SE |
| K770185 | RH Control DiluentKSZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/14/1977SE |
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| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Blood Grouping Sys., BG-9 cleared by the FDA?
Blood Grouping Sys., BG-9 (K771098) received a 510(k) decision of Substantially Equivalent on August 4, 1977, 45 days after the submission was received.
What is the product code of K771098?
The FDA product code is KSZ – System, Test, Automated Blood Grouping And Antibody, a Class II (moderate risk) device regulated under 21 CFR 864.9175.