Formalin Solution 10% Neutral Buffer
FDA 510(k) K840926 · Sigma Chemical Co.
510(k) numberK840926
Submission
- Device name
- Formalin Solution 10% Neutral Buffer
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- March 2, 1984
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K872140 | (Msi) Path-SaverIFP · Traditional | Medical Specialties, Inc. | 06/15/1987SE |
| K870852 | NBF 10% Neutral Buffered FormalinIFP · Traditional | Anatech, Ltd. | 03/31/1987SE |
| K853497 | Prefilled Specimen Jars 10% Neutral Buf-FormalinIFP · Traditional | Surgipath Medical Industries, Inc. | 08/28/1985SE |
| K842982 | Formalin BufferedIFP · Traditional | Reagent Laboratory, Inc. | 10/01/1984SE |
| K842940 | Cba FormalinIFP · Traditional | Anatech, Ltd. | 08/28/1984SE |
| K842728 | Buf-FixIFP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K830583 | Neutral Buffered Formalin 10%IFP · Traditional | Surgipath Medical Industries, Inc. | 03/17/1983SE |
| K830582 | Millonig's Modified Phosphate BufferedIFP · Traditional | Surgipath Medical Industries, Inc. | 03/17/1983SE |
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Questions and answers
When was Formalin Solution 10% Neutral Buffer cleared by the FDA?
Formalin Solution 10% Neutral Buffer (K840926) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 10 days after the submission was received.
What is the product code of K840926?
The FDA product code is IFP – Formalin, Neutral Buffered, a Class I (low risk) device regulated under 21 CFR 864.4010.