Unitized Hematology Set 65132/93
FDA 510(k) K840477 · Emd Chemicals, Inc.
510(k) numberK840477
Submission
- Device name
- Unitized Hematology Set 65132/93
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- February 3, 1984
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIF – Diluent, Blood Cell
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8200
- Specialty
- Hematology
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| K882267 | Sysmex Quicklyser-Ii (QLS-200A)GIF · Traditional | Toa Medical Electronics USA, Inc. | 07/12/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | Abbott Diagnostics | 03/31/1988SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · Traditional | Abbott Diagnostics | 09/09/1987SE |
| K851843 | Osmocel 3GIF · Traditional | Hematology Marketing Assoc. | 07/30/1985SE |
| K851320 | Sdi Prepax Dilukit M.GIF · Traditional | Scientific Distributors, Inc. | 07/05/1985SE |
| K851280 | Dass PackGIF · Traditional | Dass, Inc. | 07/05/1985SE |
| K850239 | Sysmex Hematological Whole Blood Diluting Reagent-GIF · Traditional | Toa Medical Electronics USA, Inc. | 04/01/1985SE |
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Questions and answers
When was Unitized Hematology Set 65132/93 cleared by the FDA?
Unitized Hematology Set 65132/93 (K840477) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 31 days after the submission was received.
What is the product code of K840477?
The FDA product code is GIF – Diluent, Blood Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.