Spot Test Ninhydrin Reagents
FDA 510(k) K842290 · Difco Laboratories, Inc.
510(k) numberK842290
Submission
- Device name
- Spot Test Ninhydrin Reagents
- Applicant
- Difco Laboratories, Inc.
Mchenry, IL, US - Received
- June 11, 1984
- Decision date
- June 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSF – Culture Media, Single Biochemical Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | Lakewood Biochemical Co., Inc. | 04/01/1988SE |
| K880126 | Lauryl Tryptose BrothJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880120 | Moellers Decarboxylase, LysineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880119 | Moellers Decarboxylase, OnithineJSF · Traditional | Hardy Media | 03/31/1988SE |
| K880139 | Onpg Test ReagentJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880135 | Nitrate BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880129 | Brilliant Green Bile BrothJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880118 | Moelloers Decarboxylase, ArginineJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880113 | Cystine Tryptic Medium W/LactoseJSF · Traditional | Hardy Media | 03/30/1988SE |
| K880112 | Cystine Tryptic Medium W/ MaltoseJSF · Traditional | Hardy Media | 03/30/1988SE |
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Questions and answers
When was Spot Test Ninhydrin Reagents cleared by the FDA?
Spot Test Ninhydrin Reagents (K842290) received a 510(k) decision of Substantially Equivalent on June 22, 1984, 11 days after the submission was received.
What is the product code of K842290?
The FDA product code is JSF – Culture Media, Single Biochemical Test, a Class I (low risk) device regulated under 21 CFR 866.2320.