Imx Folate
FDA 510(k) K943691 · Abbott Mfg., Inc.
510(k) numberK943691
Submission
- Device name
- Imx Folate
- Applicant
- Abbott Mfg., Inc.
Abbott Park, IL, US - Received
- July 29, 1994
- Decision date
- March 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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| K082340 | Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…CGN · Traditional | Roche Diagnostics Corp. | 06/19/2009SE |
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Questions and answers
When was Imx Folate cleared by the FDA?
Imx Folate (K943691) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 237 days after the submission was received.
What is the product code of K943691?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.