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FDA 510(k)

NORMAL UNASSAYED CONTROL SERA

K-Number: K780351 · 1978-04-24

ApplicantMacomb Chemical Co.
Decision Date1978-04-24
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORMAL UNASSAYED CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1978-04-24 under 510(k) number K780351. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL UNASSAYED CONTROL SERA?

NORMAL UNASSAYED CONTROL SERA is a medical device that received FDA 510(k) clearance on 1978-04-24. The listed applicant is Macomb Chemical Co.. The 510(k) number is K780351.

When did NORMAL UNASSAYED CONTROL SERA receive FDA 510(k) clearance?

NORMAL UNASSAYED CONTROL SERA received FDA 510(k) clearance on 1978-04-24, under 510(k) number K780351.

Who is the listed applicant for NORMAL UNASSAYED CONTROL SERA?

The FDA 510(k) record lists Macomb Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMAL UNASSAYED CONTROL SERA?

The FDA product code for NORMAL UNASSAYED CONTROL SERA is JJY.

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Other records listing Macomb Chemical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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