Wescor Gram Stain Pack for Model 7300 Aerospray
FDA 510(k) K881512 · Wescor, Inc.
510(k) numberK881512
Submission
- Device name
- Wescor Gram Stain Pack for Model 7300 Aerospray
- Applicant
- Wescor, Inc.
Logan, UT, US - Received
- April 11, 1988
- Decision date
- April 18, 1988
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K121823 | Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer…JFS · Traditional | 03/27/2013SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | 03/20/2001SE |
| K863395 | Wescor Sweat.Chek Sweat Conductivity AnalyzerCGZ · Traditional | 05/24/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | 05/13/1988SE |
| K880544 | Wescor Stain Concentrate for Model 7100 AerosprayGJL · Traditional | 04/01/1988SE |
| K853973 | Wescor Model 3700 Webster Sweat InducerKTB · Traditional | 10/16/1985SE |
| K834214 | Wescor 5500 Vapor Pressure OsmometerJJM · Traditional | 03/30/1984SE |
| K834208 | Colloid Osmometer 4400JJM · Traditional | 03/23/1984SE |
| K840472 | Sys Macroduct Sweat Collection Sys 3600KTB · Traditional | 03/19/1984SE |
| K833295 | Wescor 7100 Aerospray Slide StainerKPA · Traditional | 10/31/1983SE |
Questions and answers
When was Wescor Gram Stain Pack for Model 7300 Aerospray cleared by the FDA?
Wescor Gram Stain Pack for Model 7300 Aerospray (K881512) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 7 days after the submission was received.
What is the product code of K881512?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.