Gram Crystal Violet/Iodine/Aceton Alchl Declr/Safr
FDA 510(k) K873413 · Lakewood Biochemical Co., Inc.
510(k) numberK873413
Submission
- Device name
- Gram Crystal Violet/Iodine/Aceton Alchl Declr/Safr
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- August 24, 1987
- Decision date
- October 6, 1987
- 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
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|---|---|---|---|
| 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 |
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| K882351 | Mueller Hinton Agar Plates P3318/1&2/P3418/P34181JTZ · Traditional | 06/28/1988SE |
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | 06/22/1988SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | 06/06/1988SE |
| K880947 | Nutrient Agar Plate, Slant Tube and Broth TubeJSG · Traditional | 04/01/1988SE |
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | 04/01/1988SE |
| K880945 | Camplyobacter Culture Media Products P3873/T3597JSJ · Traditional | 03/30/1988SE |
| K875136 | Columbia Blood Agar P3308/ Columbia Cna P3750JSG · Traditional | 01/12/1988SE |
| K874538 | Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516JSG · Traditional | 11/20/1987SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | 11/20/1987SE |
Questions and answers
When was Gram Crystal Violet/Iodine/Aceton Alchl Declr/Safr cleared by the FDA?
Gram Crystal Violet/Iodine/Aceton Alchl Declr/Safr (K873413) received a 510(k) decision of Substantially Equivalent on October 6, 1987, 43 days after the submission was received.
What is the product code of K873413?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.