Gram Stain
FDA 510(k) K843050 · Reagent Laboratory, Inc.
510(k) numberK843050
Submission
- Device name
- Gram Stain
- Applicant
- Reagent Laboratory, Inc.
Mchenry, IL, US - Received
- August 3, 1984
- Decision date
- September 11, 1984
- 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 |
|---|---|---|
| K863502 | Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional | 10/21/1986SE |
| K863503 | HemolyseGGK · Traditional | 10/03/1986SE |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | 10/02/1986SE |
| K860143 | Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional | 02/10/1986SE |
| K842982 | Formalin BufferedIFP · Traditional | 10/01/1984SE |
| K842785 | Stain, Methylene Blue-EosinKFC · Traditional | 09/11/1984SE |
| K841847 | Lithium ReagentJJO · Traditional | 08/17/1984SE |
| K843051 | Wrights Stain Solution · Traditional | 08/03/1984SESP |
| K841800 | Lysing & Hemoglobin ReagentGGK · Traditional | 05/31/1984SE |
| K841799 | Cyanomethemoglobin ReagentGIF · Traditional | 05/31/1984SE |
Questions and answers
When was Gram Stain cleared by the FDA?
Gram Stain (K843050) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 39 days after the submission was received.
What is the product code of K843050?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.