Liquichek HEMATOLOGY-16 Control, Low, Normal and High
FDA 510(k) K942209 · Bio-Rad
510(k) numberK942209
Submission
- Device name
- Liquichek HEMATOLOGY-16 Control, Low, Normal and High
- Applicant
- Bio-Rad
Anaheim, CA, US - Received
- May 5, 1994
- Decision date
- June 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JCN – Control, Cell Counter, Normal And Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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| K911582 | Stak-ChexJCN · Traditional | Streck Laboratories, Inc. | 05/28/1991SE |
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| K902389 | Tri-Count 16JCN · Traditional | Hematronix, Inc. | 08/22/1990SE |
| K901875 | Para 12 PlusJCN · Traditional | Streck Laboratories, Inc. | 05/30/1990SE |
| K896154 | Para Tech for Technicon H-1JCN · Traditional | Streck Laboratories, Inc. | 11/09/1989SE |
| K895373 | Hematology ControlJCN · Traditional | Medical Specialties Intl., Inc. | 10/06/1989SE |
| K891907 | Qbc(R) Centrifugal Hematology Contr/Multi ModifiedJCN · Traditional | R&D Systems, Inc. | 04/11/1989SE |
| K874386 | Cbc-Tech(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/30/1987SE |
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Questions and answers
When was Liquichek HEMATOLOGY-16 Control, Low, Normal and High cleared by the FDA?
Liquichek HEMATOLOGY-16 Control, Low, Normal and High (K942209) received a 510(k) decision of Substantially Equivalent on June 16, 1994, 42 days after the submission was received.
What is the product code of K942209?
The FDA product code is JCN – Control, Cell Counter, Normal And Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.8625.