510(k) K821977
- Device
- GRAMSTAIN SET
- Applicant
- GRANITE DIAGNOSTICS, INC.
- 510(k) number
- K821977
- Product code
- HYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-22
- Date received
- 1982-07-06
- Regulation
- 864.1850
- Classification name
- Iodine, Grams
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1937990
- 9610140
- 1625587
- 3009963993
- 3002805583
- 1000138378
- 3006365273
- 1924669
- 2247035
- 2013736
- 1419699
- 2250039
- 1125908
- 1831638
- 3009432145
- 1711690
- 3016741564
- 2028492
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871286 | GRAM IODINE | Remel Co. | 1987-04-08 |
| K842733 | GRAM IODINE | E K Ind., Inc. | 1984-08-10 |
| K811722 | PARA-PAK | Meridian Diagnostics, Inc. | 1981-07-15 |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 |
| K781584 | GRAM STAIN KIT | Bioscientific | 1978-10-10 |
Legacy Summary#
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FDA Review#
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