Rellplate C Kit, Rellplate C Bulk Plates
FDA 510(k) K884940 · American Diagnostic Corp.
510(k) numberK884940
Submission
- Device name
- Rellplate C Kit, Rellplate C Bulk Plates
- Applicant
- American Diagnostic Corp.
New York, NY, US - Received
- November 28, 1988
- Decision date
- March 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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| K935944 | Proscopes and AdscopesLDE · Traditional | 03/03/1994SE |
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Questions and answers
When was Rellplate C Kit, Rellplate C Bulk Plates cleared by the FDA?
Rellplate C Kit, Rellplate C Bulk Plates (K884940) received a 510(k) decision of Substantially Equivalent on March 13, 1989, 105 days after the submission was received.
What is the product code of K884940?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.