Accra-Lab Gram Stain Set 55760
FDA 510(k) K811780 · Accra Laboratories, Inc.
510(k) numberK811780
Submission
- Device name
- Accra-Lab Gram Stain Set 55760
- Applicant
- Accra Laboratories, Inc.
Mchenry, IL, US - Received
- June 23, 1981
- Decision date
- July 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTS – Stains, Microbiologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code JTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960095 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 03/19/1996SE |
| K960090 | Calcofluor White Stain KitJTS · Traditional | Remel Co. | 03/19/1996SE |
| K920976 | Bactidrop India InkJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920975 | Bactidrop Calcofluor WhiteJTS · Traditional | Remel Co. | 06/09/1992SE |
| K920970 | Bactidrop Koh (10%)JTS · Traditional | Remel Co. | 06/09/1992SE |
| K893530 | Iristain Formula 2, Parts 1 and 2JTS · Traditional | Intl. Remote Imaging Systems | 06/13/1989SE |
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | Alpha-Tec Systems, Inc. | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | Alpha-Tec Systems, Inc. | 02/24/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | Scientific Device Laboratory, Inc. | 10/25/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | Scientific Device Laboratory, Inc. | 08/30/1988SE |
More from Scientific Device Laboratory, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851494 | Two-Step Acid Fast Bacteria StainJTS · Traditional | 04/29/1985SE |
| K851493 | Kinyoun Acid Fast Stain KitJTS · Traditional | 04/29/1985SE |
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | 10/02/1984SE |
| K843425 | Harris Hematoxylin, Mercury Free, AcidHYK · Traditional | 10/02/1984SE |
| K843428 | BiofixLDZ · Traditional | 09/27/1984SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | 09/27/1984SE |
| K843429 | Gram Stain Set W/Stabilized IodineJTS · Traditional | 09/14/1984SE |
| K831090 | Hematoxylin Gill Formulation IX#56016HYJ · Traditional | 06/08/1983SE |
| K830542 | Hemaquik II Staining Solution #55961IAF · Traditional | 03/17/1983SE |
| K823329 | Papincolabu Stain EA-36/50/65 & OG-6HZL · Traditional | 12/28/1982SE |
Questions and answers
When was Accra-Lab Gram Stain Set 55760 cleared by the FDA?
Accra-Lab Gram Stain Set 55760 (K811780) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 34 days after the submission was received.
What is the product code of K811780?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.