Spottest Iodine Solution Dobell & O'Connor
FDA 510(k) K851481 · Difco Laboratories, Inc.
510(k) numberK851481
Submission
- Device name
- Spottest Iodine Solution Dobell & O'Connor
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- April 15, 1985
- Decision date
- April 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LED – Stains, Chemical Solution
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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| K860320 | GranulocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
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| K860317 | NeutrocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860316 | PanoptikonLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K854176 | Polychrome IV StainLED · Traditional | Devetec, Inc. | 10/31/1985SE |
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Questions and answers
When was Spottest Iodine Solution Dobell & O'Connor cleared by the FDA?
Spottest Iodine Solution Dobell & O'Connor (K851481) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 14 days after the submission was received.
What is the product code of K851481?
The FDA product code is LED – Stains, Chemical Solution, a Class I (low risk) device regulated under 21 CFR 864.1850.