Iodine, Grams
Gram's iodine is a histological and microbiological staining reagent used as a mordant in the Gram stain procedure to differentiate bacterial species into gram-positive and gram-negative categories based on their cell wall properties, as well as in histology for certain carbohydrate staining methods. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYI falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYI
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871286 | GRAM IODINE | Apr 08, 1987 | Substantially Equivalent | Remel Co. |
| K842733 | GRAM IODINE | Aug 10, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K821977 | GRAMSTAIN SET | Jul 22, 1982 | Substantially Equivalent | Granite Diagnostics, Inc. |
| K811722 | PARA-PAK | Jul 15, 1981 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Oct 17, 1979 | Substantially Equivalent | Carr-Scarborough Microbiologicals, Inc. |
| K781584 | GRAM STAIN KIT | Oct 10, 1978 | Substantially Equivalent | Bioscientific |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.